Maxx Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Maxx Orthopedics, Inc.” (first 2009, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 101 days. Since 2017 the median was 88 days, against 92 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 371 |
| 2013 | 0 | — |
| 2014 | 1 | 275 |
| 2015 | 1 | 101 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 168 |
| 2019 | 4 | 103 |
| 2020 | 2 | 298 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 65 |
| 2025 | 7 | 30 |
| 2026 | 3 | 88 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Maxx Orthopedics, Inc. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 15 | 15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 3 | 3 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (25)
Most recent Maxx Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | JWH | 2026-08-07 | 88 |
| K261609 | Freedom Partial Knee System | HSX | 2026-08-04 | 82 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | LZO | 2026-01-15 | 111 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | MBH | 2025-10-31 | 59 |
| K253314 | Freedom Infinia Total Knee System | JWH | 2025-10-29 | 29 |
| K253144 | Freedom® Total Knee System Titan PCK Components | JWH | 2025-10-22 | 27 |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | KWY | 2025-08-25 | 273 |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | JWH | 2025-06-26 | 22 |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | JWH | 2025-03-13 | 30 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | MBH | 2025-02-13 | 255 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Maxx Orthopedics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Maxx Orthopedics, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02056470: Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System (Completed, started 2013-09)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Maxx Digm, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maxx Orthopedics, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Maxx Orthopedics, Inc.” (first 2009, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Maxx Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maxx Orthopedics, Inc. is 101 days. Since 2017: 88 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Maxx Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are 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).
Next steps
- See all 25 Maxx Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Maxx Orthopedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.