Data / Medical devices / United States / Wright Medical Technology, Inc.
Wright Medical Technology, Inc.: FDA-registered device maker in Arlington, TN, United States, 209 510(k) clearances and 1 PMA approval
Wright Medical Technology, Inc. is registered with the FDA (registration 3010667733) in Arlington, TN, United States. It lists 92 device types. The FDA files 209 510(k) clearances and 1 PMA approval under its listings, the newest dated June 16, 2026. 20 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010667733
- Address
- 11500 Memphis Arlington Road, Arlington, TN, United States, 38002
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 10, 1978
- Registered through
- 2027
- Brand names listed
- 10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10mm SUBFIX TRIAL, 11.5MM FLEXIBLE REAMER, 11.5mm SUBFIX TRIAL, 11MM FLEXIBLE REAMER, 12MM FLEXIBLE REAMER, 135 mm Reusable Slat, SE Retr, 10 Pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ankle Arthroplasty Implantation System | OYK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Applier, Cerclage | HXN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Component, Traction, Invasive | JEC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dispenser, Cement | KIH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Synthetic Peptide | NOX | 3 | Complaint file establishment | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Specification developer | accessdata.fda.gov |
| Fork | HXE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Finger, Polymer | KWF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Tendon, Passive | HXA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Toe, Constrained, Polymer | KWH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Wrist, Carpal Lunate | KWN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Wrist, Carpal Scaphoid | KWO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Wrist, Carpal Trapezium | KYI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Punch, Femoral Neck | HWP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Specification developer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Saw | HSO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spatula, Orthopedic | HXR | 1 | Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, 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 209.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2026 | K253159 | Prophecy Incompass Surgical Planning System | HSN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker) | accessdata.fda.gov |
| October 29, 2025 | K251643 | Synchfix EVT | HTN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker Corporation) | accessdata.fda.gov |
| September 30, 2025 | K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | MQV | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker Corporation) | accessdata.fda.gov |
| June 20, 2025 | K250037 | Incompass Total Ankle System | HSN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker) | accessdata.fda.gov |
| November 1, 2024 | K241999 | Prophecy Surgical Planning System | HSN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker) | accessdata.fda.gov |
| February 17, 2023 | K221645 | PROstep(TM) MIS 5mm Chamfer Screw System | HWC | Substantially Equivalent | Wright Medical Technology | accessdata.fda.gov |
| January 27, 2023 | K222835 | Prophecy Preoperative Navigation Alignment System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 5, 2022 | K213342 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 16, 2021 | K212996 | Sterile PHALINX Hammertoe System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 11, 2021 | K203228 | DART-FIRE EDGE Cannulated Screw System | HWC | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| May 7, 2021 | K203832 | FuseForce Flex Dynamic Compression System | JDR | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| March 10, 2021 | K202815 | PROPHECY Preoperative Navigation Alignment System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 8, 2020 | K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 22, 2019 | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 13, 2019 | K190970 | PROSTEP TBI (Tailors Bunion Implant) System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 6, 2019 | K183620 | PROSTEP TBC Implant System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 28, 2019 | K190482 | IGNITE Bone Void Filler | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 14, 2019 | K190670 | ORTHOLOC 2 Lapidus with Rotation System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 14, 2019 | K190283 | PROSTIM Injectable Inductive Graft | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 13, 2019 | K183026 | Wright Jones Fracture System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 12, 2018 | K181255 | PRODENSE Bone Graft Substitute | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 9, 2018 | K181557 | INFINITY Total Ankle System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 11, 2018 | K180024 | SALVATION Midfoot Nail | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 6, 2018 | K180832 | SALVATION External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 26, 2018 | K172633 | INFINITY Total Ankle System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 21, 2017 | K171852 | DARCO Locking Bone Plate System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 11, 2017 | K171067 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 22, 2017 | K170642 | GRAVITY Soft Tissue Repair System | GAT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 16, 2017 | K170968 | PROPHECY INVISION Pre-operative Navigation System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 30, 2017 | K170249 | GRAVITY Syndesmosis LP | HTN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 26, 2017 | K170889 | HV Screw System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 24, 2017 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 13, 2017 | K162353 | MICATM Screw System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 13, 2017 | K163039 | ORTHOLOC® 3Di Small Bones Plating | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 6, 2017 | K162033 | SALVATION External Fixation System | KTT | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| February 23, 2017 | K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | MBI | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 22, 2017 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 26, 2017 | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 6, 2016 | K161447 | HydroSet XT | MQV | Substantially Equivalent | Orthovita, Inc. | accessdata.fda.gov |
| May 17, 2016 | K152062 | BIOFOAM Bone Wedge | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 6, 2016 | K153008 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 13, 2016 | K153635 | SALVATION(R) External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 11, 2015 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 4, 2015 | K151838 | PRO-TOE Hammertoe Fixation System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 21, 2015 | K152045 | SALVATION® External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 20, 2015 | K142724 | BIOFOAM Bone Wedge | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 8, 2015 | K150213 | Subtalar Spacer System (STS) | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 29, 2015 | K150520 | DARCO Locking Bone Plate System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 29, 2015 | K150252 | PHALINX Hammertoe System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 25, 2015 | K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 5, 2015 | K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 4, 2015 | K150004 | SALVATION External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 10, 2015 | K150073 | MICRONAIL Distal Radius System | HSB | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 23, 2015 | K143460 | Cannulated Screw System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 8, 2015 | K143220 | SIDEKICK EZ FRAME External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 15, 2014 | K142490 | ProxiFuse Hammer Toe Device | HWC | Substantially Equivalent | Cartiva, Inc. | accessdata.fda.gov |
| December 5, 2014 | K143025 | TOTAL COMPRESSION PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 20, 2014 | K142585 | PhaLinx Hammertoe System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 24, 2014 | K141714 | PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM | HTY | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 22, 2014 | K142602 | VALOR Hindfoot Fusion Nail System | HSB | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 21, 2014 | K142121 | VALOR HINDFOOT FUSION NAIL SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 30, 2014 | K141011 | G-FORCE GEN 2 SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 9, 2014 | K141417 | CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 9, 2014 | K140531 | BIOFOAM BONE WEDGE | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 22, 2014 | K140792 | SALVATION 3DI PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 15, 2014 | K140952 | CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 15, 2014 | K140741 | SALVATION BEAMS AND BOLTS SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 14, 2014 | K140408 | SALVATION OSTEOPENIC SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 25, 2014 | K140749 | INFINITY TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 24, 2014 | K132656 | PRODENSE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 7, 2014 | K140148 | PRO-TOE HAMMERTOE FIXATION SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 7, 2014 | K133713 | CHARLOTTE (TM) SNAP-OFF SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 28, 2014 | K133715 | CHARLOTTE CLAW PLATE SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 20, 2014 | K133585 | INBONE TOTAL ANKLE | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 13, 2013 | K132594 | CROSSCHECK PLATING SYSTEM | HRS | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| October 23, 2013 | K132895 | WMT IMPLANTABLE K-WIRE | HTY | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 22, 2013 | K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | KWD | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| July 10, 2013 | K124045 | FUSEFORCE IMPLANT SYSTEM | JDR | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| July 5, 2013 | K131283 | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 21, 2013 | K131093 | ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 5, 2013 | K130044 | SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 1, 2013 | K123954 | INFINITY TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 4, 2013 | K123059 | INBONE ( I AND II) TOTAL ANKLE SYSTEMS | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 9, 2012 | K121356 | MICRO/MINI N-PK(H) BONE ANCHOR | MBI | Substantially Equivalent | Anulex Technologies, Inc. | accessdata.fda.gov |
| November 7, 2012 | K122738 | GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | HWC | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| October 12, 2012 | K121651 | ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 1, 2012 | K121425 | ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 25, 2012 | K113006 | I-FUSE HAMMER TOE SYSTEMS | HWC | Substantially Equivalent | Orthopro, LLC | accessdata.fda.gov |
| May 3, 2012 | K120359 | ORTHOLOC 3DI HALLUX SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 24, 2012 | K120645 | PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 10, 2012 | K120390 | SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | HWC | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| April 2, 2012 | K120802 | ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 6, 2012 | K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | KWD | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| February 6, 2012 | K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | KWD | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| January 31, 2012 | K113014 | CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 16, 2011 | K110360 | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 12, 2011 | K113339 | ORTHOLOC 3DSI LOCKING SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 7, 2011 | K112772 | ORTHOLOC(TM) BONE SCREWS | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 19, 2011 | K111432 | EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 4, 2011 | K102324 | ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | 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 |
|---|---|---|---|---|---|---|
| September 1, 2015 | P100006 | AUGMENT BONE GRAFT | NOX | 12 | June 13, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 18, 2026 | 99651 | Class II | Ongoing | CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System | Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement d | accessdata.fda.gov |
| March 6, 2024 | 94194 | Class II | Ongoing | stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide. | accessdata.fda.gov |
| June 13, 2023 | 92460 | Class II | Ongoing | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. | accessdata.fda.gov |
| April 10, 2023 | 92078 | Class II | Ongoing | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | accessdata.fda.gov |
| February 2, 2023 | 91673 | Class II | Ongoing | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa. | accessdata.fda.gov |
| September 30, 2022 | 90965 | Class II | Terminated | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 | The tibial tray lock detail is oversized (larger than specification). | accessdata.fda.gov |
| August 3, 2022 | 90772 | Class II | Ongoing | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two s | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | accessdata.fda.gov |
| July 27, 2022 | 90660 | Class II | Ongoing | Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile. | An incorrect sizing label was applied to the carton packaging. | accessdata.fda.gov |
| June 14, 2022 | 90399 | Class II | Ongoing | Wright EVOLVE TRIAD Plate Cutter, REF 49510120 | The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use | accessdata.fda.gov |
| June 2, 2022 | 90216 | Class II | Ongoing | Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System. | The instrument is incorrectly color coded. | accessdata.fda.gov |
| March 10, 2022 | 89739 | Class II | Terminated | EasyFuse Dynamic Compression System Instrument Pack | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. | accessdata.fda.gov |
| February 15, 2022 | 89507 | Class II | Terminated | Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System. | An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. | accessdata.fda.gov |
| February 9, 2022 | 89461 | Class II | Terminated | The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plate | Product was labelled with the incorrect manufacturing and distribution dates. | accessdata.fda.gov |
| December 3, 2021 | 89086 | Class II | Ongoing | Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System. | Incorrect product is contained in the packaging. | accessdata.fda.gov |
| July 28, 2020 | 85982 | Class II | Terminated | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete ran | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | accessdata.fda.gov |
| December 27, 2019 | 84673 | Class II | Terminated | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. | accessdata.fda.gov |
| July 21, 2015 | 71895 | Class II | Terminated | CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 | These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. | accessdata.fda.gov |
| April 16, 2015 | 71143 | Class II | Terminated | PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | accessdata.fda.gov |
| March 6, 2015 | 70859 | Class II | Terminated | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use. | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | accessdata.fda.gov |
| July 30, 2014 | 69058 | Class II | Terminated | CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic | Plates manufactured from an incorrect raw material. | accessdata.fda.gov |
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Updated October 1, 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.