Data / Medical devices / United States / Microport Orthopedics Inc.
Microport Orthopedics Inc.: FDA-registered device maker in Arlington, TN, United States, 140 510(k) clearances and 3 PMA approvals
Microport Orthopedics Inc. is registered with the FDA (registration 3010536692) in Arlington, TN, United States. It lists 102 device types. The FDA files 140 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 15, 2025. 15 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010536692
- Address
- 5677 Airline RD, Arlington, TN, United States, 38002
- Owner or operator
- MicroPort Orthopedics Inc. (10045253)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- October 31, 2013
- Registered through
- 2026
- Brand names listed
- 18711131 STRYKER SAW BLADE 2000 NARROW STERILE, 18711132 STRYKER SAW BLADE 2000 WIDE STERILE, 18711133 HALL 7 HOLE SAW BLADE NARROW, 18951018 ADVANTIM® POST STAB FEM LG LEFT NONPOROUS OPEN HOUSING, ADVANCE® Double High Insert, AXIOM® Second Generation Knee System, Advance, Advantim and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Cerclage | HXN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bone Cement | LOD | 2 | Manufacturer | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cap, Bone | JDT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cement Obturator | LZN | 2 | Manufacturer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| File | HTP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | 2 | Manufacturer | accessdata.fda.gov |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | 2 | Manufacturer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knee Arthroplasty Implantation System | OOG | 2 | Manufacturer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | LPF | 3 | Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | MRA | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | NXT | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 2 | Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Hinged (Metal-Metal) | HRZ | 3 | Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Punch, Femoral Neck | HWP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saw | HSO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Skid, Bone | HWO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Orthopedic | HXR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trephine | HWK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 140.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2025 | K250444 | NEXUS® Hip Stem | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| February 18, 2025 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | JWH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| April 12, 2024 | K240452 | Ceramic Femoral Head | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| January 18, 2024 | K233507 | EVOLUTION® Tibial Cones | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| October 31, 2023 | K231947 | EVOLUTION® Cement Keel | JWH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| September 27, 2023 | K230563 | EVOLUTION® Hinge Knee System | KRO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| January 5, 2022 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| January 5, 2022 | K213816 | MPO Hip Instruments | JDI | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| October 1, 2021 | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | LPH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| August 24, 2021 | K201157 | Prime BIOFOAM® Multi-Hole Shells | MBL | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| August 20, 2021 | K202705 | Prime and DYNASTY® Additive Manufacturing Shells | OQG | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| December 10, 2020 | K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | JDI | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| April 25, 2020 | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| October 7, 2019 | K191632 | PROFEMUR TL2 Stems | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| July 15, 2019 | K190123 | MicroPort CoCr Femoral Heads | LPH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| May 16, 2019 | K182251 | EVOLUTION NitrX Medial-Pivot Knee | JWH | Substantially Equivalent | Mircoport Orthopedics, Inc. | accessdata.fda.gov |
| December 6, 2018 | K182125 | EVOLUTION Stemmed CS Femur | JWH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| September 14, 2018 | K181598 | Prime E-CLASS XLPE Liner | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| July 9, 2018 | K180798 | Prime Acetabular Cup System | LPH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| July 6, 2018 | K173776 | BIOLOX delta Option and Extra-long Heads | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| May 4, 2018 | K180317 | EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| August 28, 2017 | K171181 | PROCOTYL® PRIME E-CLASS XLPE Liner | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| August 8, 2017 | K171389 | EVOLUTION Revision CCK System | JWH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| June 26, 2017 | K170444 | PROCOTYL® PRIME Acetabular Cup System | LPH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| March 1, 2017 | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions | JWH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| November 16, 2015 | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| April 20, 2015 | K150133 | PROFEMUR Preserve Size 1-3 Hip Stems | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| April 10, 2015 | K150302 | PROFEMUR Preserve Classic Stem | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| February 27, 2015 | K142119 | PROCOTYL L-O ACETABULAR SYSTEM | LPH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| January 21, 2015 | K143366 | ADVANCE Porous Coated Spiked Tibial Base | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| November 7, 2014 | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments | JWH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| September 12, 2014 | K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| August 29, 2014 | K140735 | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS | MBH | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| May 30, 2014 | K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| April 3, 2014 | K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD | LZO | Substantially Equivalent | Microport Orthopedics, Inc. | accessdata.fda.gov |
| October 23, 2013 | K131679 | EVOLUTION MP ADAPTIVE PS TIBIAL INSERT | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 3, 2013 | K130376 | DYNASTY ACETABULAR SYSTEM WITH CERAMIC | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 24, 2013 | K130984 | PROFEMUR RENAISSANCE CLASSIC HIP STEM | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 21, 2013 | K122218 | ADVANCE TOTAL KNEE SYSTEM-PATELLA | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 8, 2013 | K123688 | PROFEMUR TL CLASSIC HIP STEM | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 5, 2013 | K123434 | PROFEMUR Z CLASSIC STEMS | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 22, 2012 | K122382 | DYNASTY BIOFOAM SHELL | MBL | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 9, 2012 | K121221 | PROFEMUR Z REVISION HIP STEM | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 28, 2011 | K112080 | PRESERVE HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 9, 2011 | K113325 | EVOLUTION MP ADAPTIVE CS INSERT | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 23, 2011 | K112150 | PROFEMUR GLADIATOR HA HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 10, 2011 | K113019 | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 17, 2011 | K103598 | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 14, 2011 | K111910 | GLADIATOR HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 19, 2011 | K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 19, 2011 | K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 10, 2011 | K110399 | GLADIATOR PLASMA CLASSIC HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 7, 2011 | K102380 | EVOLUTION MP TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 28, 2010 | K100866 | PROFEMUR HIP SYSTEM MODULAR NECKS | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 4, 2010 | K093552 | EVOLUTION MP TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 25, 2009 | K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 20, 2009 | K092201 | ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 20, 2009 | K081479 | ADVANCE A-CLASS TIBIAL INSERT | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 12, 2008 | K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | KXA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 15, 2008 | K081090 | PROFEMUR LX 5/8 COATED HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 8, 2008 | K080663 | PROFEMUR LX REVISION 5/8 COATED HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 6, 2008 | K072656 | DYNASTY CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 9, 2008 | K072367 | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR | KRO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 11, 2007 | K070785 | DYNASTY ACETABULAR SYSTEM | JDL | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 21, 2007 | K063128 | ADVANCE SPIKED POROUS TIBIAL BASE | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 2, 2007 | K063731 | ADVANCE STATURE FEMORAL COMPONENT | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 1, 2006 | K062960 | CONSERVE FEMORAL RESURFACING COMPONENT | KXA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 29, 2006 | K062693 | GLADIATOR BIPOLAR SYSTEM | KWY | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 18, 2006 | K061223 | ADVANCE TOTAL KNEE SYSTEM | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 3, 2006 | K061547 | DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER | LPH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 10, 2006 | K060358 | PROFEMUR TL HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 27, 2006 | K052915 | PROFEMUR XTR HIP STEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 5, 2005 | K052026 | LINEAGE A-CLASS POLY LINER | LPH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 22, 2005 | K051995 | PROFEMUR RENAISSANCE HIP STEM | JDL | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 4, 2005 | K043073 | PROCOTYL-E ACETABULAR SYSTEM | KWA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 18, 2005 | K043083 | ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL | MBH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 15, 2004 | K033890 | ADVANCE DOUBLE HIGH INSERT | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 4, 2002 | K021489 | REPIPHYSIS LIMB SALVAGE SYSTEM | KRO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 2, 2002 | K021346 | STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX | LPH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 7, 2001 | K013035 | GUARDIAN LIMB SALVAGE SYSTEM | KRO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 3, 2001 | K012091 | PRO-FEMUR | LZO | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 15, 2001 | K004032 | PERFECTA AND EXTEND | LPH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 13, 2000 | K003016 | PRO-FEMUR R | LWJ | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 31, 2000 | K002149 | LINEAGE ACETABULAR SYSTEM | LPH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 3, 1999 | K990030 | ADVANCED REVISION PRODUCT LINE EXTENSION | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 12, 1997 | K973524 | ADVANCE MODULAR TIBIAL COMPONENT | JWH | Substantially Equivalent for Some Indications | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 21, 1997 | K972770 | ADVANCE ULTRA-CONGRUENT TIBIAL INSERT | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 29, 1997 | K972626 | ADVANCE KNEE SYSTEM | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 8, 1997 | K964218 | PERFECTA PLASMA SPRAY HIP STEM | JDI | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 8, 1996 | K960617 | ADVANCE TIBIAL COMPONENT | HRY | Substantially Equivalent for Some Indications | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 30, 1996 | K953439 | ULTRACK TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 18, 1996 | K955229 | WRIGHT MEDICAL TECHNOLOGY SAWBLADES | GFA | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 8, 1995 | K953025 | SLT 28MM XXL FEMORAL HEAD | JDI | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 22, 1995 | K935080 | INSALL-BURSTEIN II | JWH | Substantially Equivalent for Some Indications | Hospital For Special Surgery | accessdata.fda.gov |
| March 17, 1995 | K945087 | ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 28, 1994 | K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | KXA | Substantially Equivalent | Orthomet, Inc. | accessdata.fda.gov |
| December 15, 1994 | K944845 | ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT | JWH | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 18, 1994 | K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER | JWH | Substantially Equivalent for Some Indications | Orthomet, Inc. | accessdata.fda.gov |
| October 14, 1994 | K932677 | AXIOM TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Orthomet, Inc. | accessdata.fda.gov |
| October 14, 1994 | K931333 | ORTHOMET ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Orthomet, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 3, 2009 | P030042 | CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM | NXT | 3 | August 8, 2011 | accessdata.fda.gov |
| July 7, 2003 | P030027 | CERAMIC TRANSCEND HIP ARTICULATION | MRA | 8 | February 16, 2018 | accessdata.fda.gov |
| February 22, 1984 | N18466 | CMW BONE CEMENT | LOD | 18 | October 21, 1998 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | 98220 | Class II | Ongoing | Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE | Due to products not having FDA Premarket authorization to be distributed within the United States. | accessdata.fda.gov |
| October 29, 2024 | 95672 | Class II | Ongoing | EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging. | accessdata.fda.gov |
| May 3, 2024 | 94729 | Class II | Ongoing | EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only. | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging. | accessdata.fda.gov |
| October 28, 2022 | 91102 | Class II | Terminated | EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging. | accessdata.fda.gov |
| May 4, 2022 | 90140 | Class II | Terminated | PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK | One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. | accessdata.fda.gov |
| July 31, 2020 | 86211 | Class II | Ongoing | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8). | accessdata.fda.gov |
| July 31, 2020 | 86153 | Class I | Terminated | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component. | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to | accessdata.fda.gov |
| September 18, 2017 | 78150 | Class II | Terminated | MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip fu | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic. | accessdata.fda.gov |
| November 17, 2016 | 75888 | Class II | Terminated | PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femor | The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach. | accessdata.fda.gov |
| June 30, 2016 | 74752 | Class II | Terminated | PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). | accessdata.fda.gov |
| June 21, 2016 | 75063 | Class III | Terminated | Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal | accessdata.fda.gov |
| June 21, 2016 | 74785 | Class I | Terminated | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, Mic | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | accessdata.fda.gov |
| August 4, 2015 | 71925 | Class I | Terminated | PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component. | Unexpected rate of postoperative fractures resulting in the need for revision surgery. | accessdata.fda.gov |
| February 2, 2015 | 70477 | Class II | Terminated | EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component. | Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product. | accessdata.fda.gov |
| April 30, 2014 | 68326 | Class II | Terminated | PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument. | Difficulty removing the cup adaptor from the impaction handle during surgery | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Scissors, Orthopedic, Surgical
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Tape, Measuring, Rulers And Calipers
Updated January 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.