Company · US
Maxx Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K260975 | Libertas Acetabular Liners (Acetabular Liner) Maxx Orthopedics, Inc. | JDI |
| Aug 7, 2026 | K261563 | Freedom Total Knee System (E-Poly Tibial Liners) Maxx Orthopedics, Inc. | JWH |
| Aug 4, 2026 | K261609 | Freedom Partial Knee System Maxx Orthopedics, Inc. | HSX |
| Jan 15, 2026 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) Maxx Orthopedics, Inc. | LZO |
| Oct 31, 2025 | K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) Maxx Orthopedics, Inc. | MBH |
| Oct 29, 2025 | K253314 | Freedom Infinia Total Knee System Maxx Orthopedics, Inc. | JWH |
| Oct 22, 2025 | K253144 | Freedom® Total Knee System Titan PCK Components Maxx Orthopedics, Inc. | JWH |
| Aug 25, 2025 | K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) Maxx Orthopedics, Inc. | KWY |
| Jun 26, 2025 | K251717 | Freedom® Total Knee System Titanium Tibial Base Plate Maxx Orthopedics, Inc. | JWH |
| Mar 13, 2025 | K250382 | Freedom Total Knee System (All-poly Tibial Plate) Maxx Orthopedics, Inc. | JWH |
| Feb 13, 2025 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate Maxx Orthopedics, Inc. | MBH |
| Nov 19, 2024 | K243277 | Freedom® Medial Congruent Liner Maxx Orthopedics, Inc. | JWH |
| Jul 2, 2024 | K240863 | Freedom® Total Knee System Maxx Orthopedics, Inc. | JWH |
| Nov 18, 2020 | K200912 | Freedom(R) - TiNbN Coated Knee Maxx Orthopedics, Inc. | JWH |
| Oct 29, 2020 | K192989 | Libertas E-XLPE Modular Liner Maxx Orthopedics, Inc. | OQI |
| Sep 5, 2019 | K192148 | Freedom Primary PCK Maxx Orthopedics, Inc. | JWH |
| Aug 23, 2019 | K183684 | Libertas Taper Uncemented Femoral Stem Maxx Orthopedics, Inc. | LZO |
| Feb 22, 2019 | K183365 | Libertas Acetabular Hooded Liner Maxx Orthopedics, Inc. | LZO |
| Jan 22, 2019 | K182574 | Freedom Ultra-Congruent CR Tibial Liner Maxx Orthopedics, Inc. | JWH |
| Sep 28, 2018 | K180973 | Libertas Hip Replacement System Maxx Orthopedics, Inc. | JDI |
| Jun 26, 2015 | K150680 | Freedom Cementless Femoral Component Maxx Orthopedics, Inc. | MBH |
| Feb 21, 2014 | K131481 | FREEDOM PCK COMPONENTS Maxx Orthopedics, Inc. | JWH |
| Jun 29, 2012 | K111785 | FREEDOM(R) STEMMED TIBIAL COMPONENTS Maxx Orthopedics, Inc. | JWH |
| Sep 25, 2009 | K091280 | FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT Maxx Orthopedics, Inc. | JWH |
| Apr 7, 2009 | K090411 | FREEDOM METAL BACKED TIBIAL COMPONENT Maxx Orthopedics, Inc. | JWH |
| Feb 6, 2009 | K082019 | FREEDOM TOTAL KNEE SYSTEM Maxx Orthopedics, Inc. | JWH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||