Maxx Orthopedics Inc.
Norristown, PA, US
MAXX ORTHOPEDICS INC. appears in FDA device records in Norristown, PA. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Maxx Orthopedics Inc. between 2009 and 2026. The busiest year on record is 2025, with 7. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 3 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 2 |
| 2024 | 2 |
| 2025 | 7 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | JWH | Substantially Equivalent | |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | LZO | Substantially Equivalent | |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | MBH | Substantially Equivalent | |
| K253314 | Freedom Infinia™ Total Knee System | JWH | Substantially Equivalent | |
| K253144 | Freedom® Total Knee System – Titan PCK Components | JWH | Substantially Equivalent | |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | KWY | Substantially Equivalent | |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | JWH | Substantially Equivalent | |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | JWH | Substantially Equivalent | |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | MBH | Substantially Equivalent | |
| K243277 | Freedom® Medial Congruent Liner | JWH | Substantially Equivalent | |
| K240863 | Freedom® Total Knee System | JWH | Substantially Equivalent | |
| K200912 | Freedom(R) - TiNbN Coated Knee | JWH | Substantially Equivalent | |
| K192989 | Libertas E-XLPE Modular Liner | OQI | Substantially Equivalent | |
| K192148 | Freedom Primary PCK | JWH | Substantially Equivalent | |
| K183684 | Libertas – Taper Uncemented Femoral Stem | LZO | Substantially Equivalent | |
| K183365 | Libertas Acetabular Hooded Liner | LZO | Substantially Equivalent | |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | JWH | Substantially Equivalent | |
| K180973 | Libertas Hip Replacement System | JDI | Substantially Equivalent | |
| K150680 | Freedom Cementless Femoral Component | MBH | Substantially Equivalent | |
| K131481 | FREEDOM PCK COMPONENTS | JWH | Substantially Equivalent | |
| K111785 | FREEDOM(R) STEMMED TIBIAL COMPONENTS | JWH | Substantially Equivalent | |
| K091280 | FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT | JWH | Substantially Equivalent | |
| K090411 | FREEDOM METAL BACKED TIBIAL COMPONENT | JWH | Substantially Equivalent | |
| K082019 | FREEDOM TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K261609 | Freedom Partial Knee System | HSX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007311878 | 3007311878 | MAXX ORTHOPEDICS INC. | 2460 General Armistead Ave, Norristown, PA 19403 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- HTQBroach
- HWRDriver, Prosthesis
- GFCDriver, Surgical, Pin
- HWBExtractor
- HTPFile
- HXEFork
- KQXGoniometer, Ac-Powered
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- HWAImpactor
- LXHOrthopedic Manual Surgical Instrument
- HTCPliers, Surgical
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HTOReamer
- HXXScrewdriver
- HWDStarter, Bone Screw
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain