Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maxx Orthopedics, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
275 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 | 88 | 0 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas | Maxx Orthopedics, Inc. | 2026-01-15 | 111 | 0 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 | 59 | 0 |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 | 29 | 0 |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 | 27 | 0 |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025-08-25 | 273 | 0 |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 | 22 | 0 |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025-03-13 | 30 | 0 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 | 255 | 0 |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | 2024-11-19 | 34 | 0 |
| K240863 | Freedom® Total Knee System | Maxx Orthopedics, Inc. | 2024-07-02 | 96 | 0 |
| K200912 | Freedom(R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | 2020-11-18 | 226 | 0 |
| K192989 | Libertas E-XLPE Modular Liner | Maxx Orthopedics, Inc. | 2020-10-29 | 370 | 0 |
| K192148 | Freedom Primary PCK | Maxx Orthopedics, Inc. | 2019-09-05 | 28 | 0 |
| K183684 | Libertas – Taper Uncemented Femoral Stem | Maxx Orthopedics, Inc. | 2019-08-23 | 238 | 0 |
| K183365 | Libertas Acetabular Hooded Liner | Maxx Orthopedics, Inc. | 2019-02-22 | 80 | 0 |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | Maxx Orthopedics, Inc. | 2019-01-22 | 126 | 0 |
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018-09-28 | 168 | 0 |
| K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics, Inc. | 2015-06-26 | 101 | 0 |
| K131481 | FREEDOM PCK COMPONENTS | Maxx Orthopedics, Inc. | 2014-02-21 | 275 | 0 |
| K111785 | FREEDOM(R) STEMMED TIBIAL COMPONENTS | Maxx Orthopedics, Inc. | 2012-06-29 | 371 | 0 |
| K091280 | FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT | Maxx Orthopedics, Inc. | 2009-09-25 | 147 | 0 |
| K090411 | FREEDOM METAL BACKED TIBIAL COMPONENT | Maxx Orthopedics, Inc. | 2009-04-07 | 48 | 0 |
| K082019 | FREEDOM TOTAL KNEE SYSTEM | Maxx Orthopedics, Inc. | 2009-02-06 | 205 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda