Data / Medical devices / United States / Maxx Orthopedics Inc.
Maxx Orthopedics Inc.: FDA-registered device maker in Norristown, PA, United States, 26 510(k) clearances
Maxx Orthopedics Inc. is registered with the FDA (registration 3007311878) in Norristown, PA, United States. It lists 30 device types. The FDA files 26 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007311878
- Address
- 2460 General Armistead Ave Suite 100, Norristown, PA, United States, 19403
- Owner or operator
- Maxx Orthopedics Inc. (10028575)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Specification developer
- First device listed
- February 12, 2009
- Registered through
- 2026
- Brand names listed
- Freedom, Freedom All-poly Baseplate, Freedom Bone Screw, Freedom Caliper, Freedom Driver, Freedom File, Freedom Fork, Freedom Hammer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| File | HTP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Fork | HXE | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Goniometer, Ac-Powered | KQX | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer, 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 15, 2026 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | LZO | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| October 31, 2025 | K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | MBH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| October 22, 2025 | K253144 | Freedom® Total Knee System Titan PCK Components | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| August 25, 2025 | K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | KWY | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| June 26, 2025 | K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| March 13, 2025 | K250382 | Freedom Total Knee System (All-poly Tibial Plate) | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| February 13, 2025 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | MBH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| November 19, 2024 | K243277 | Freedom® Medial Congruent Liner | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| July 2, 2024 | K240863 | Freedom® Total Knee System | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| June 16, 2022 | K212870 | TLC Unicompartmental Knee System | HSX | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| November 18, 2020 | K200912 | Freedom(R) - TiNbN Coated Knee | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| October 29, 2020 | K192989 | Libertas E-XLPE Modular Liner | OQI | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| September 5, 2019 | K192148 | Freedom Primary PCK | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| August 23, 2019 | K183684 | Libertas Taper Uncemented Femoral Stem | LZO | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| February 22, 2019 | K183365 | Libertas Acetabular Hooded Liner | LZO | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| January 22, 2019 | K182574 | Freedom Ultra-Congruent CR Tibial Liner | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| September 28, 2018 | K180973 | Libertas Hip Replacement System | JDI | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| January 29, 2018 | K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | KWY | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| June 26, 2015 | K150680 | Freedom Cementless Femoral Component | MBH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| July 22, 2014 | K133370 | REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE | LPH | Substantially Equivalent | Signature Orthopaedics Pty Limited | accessdata.fda.gov |
| February 21, 2014 | K131481 | FREEDOM PCK COMPONENTS | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| June 29, 2012 | K111785 | FREEDOM(R) STEMMED TIBIAL COMPONENTS | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| September 25, 2009 | K091280 | FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| April 7, 2009 | K090411 | FREEDOM METAL BACKED TIBIAL COMPONENT | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| February 6, 2009 | K082019 | FREEDOM TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Maxx Orthopedics, Inc. | accessdata.fda.gov |
| February 19, 2008 | K072704 | UNICOMPARTMENTAL KNEE | HRY | Substantially Equivalent | Valpo Orthopedic Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pliers, Surgical
- All makers of Broach
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- All makers of Starter, Bone Screw
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated January 15, 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.