510(k) K261609
- Device
- Freedom Partial Knee System
- Applicant
- Maxx Orthopedics, Inc.
- 510(k) number
- K261609
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-04
- Date received
- 2026-05-14
- Regulation
- 888.3520
- Classification name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Asawari Hare
- Address
- 2460 General Armistead Ave. #100 Norristown PA US 19403 19403
FDA Registration Numbers#
- 1000517406
- 1000200989
- 3002808022
- 3009241418
- 3010041693
- 1000550978
- 3011061242
- 3002579136
- 3009888344
- 3012319330
- 1057425
- 3015398319
- 3015542154
- 3013176080
- 3036756245
- 3004142400
- 9616680
- 1827096
- 1226544
- 9613369
- 2245304
- 1220246
- 1834331
- 1061927
- 1220477
- 2028632
- 1222928
- 3006395932
- 2528981
- 3006946276
- 3009848551
- 9616671
- 3007963827
- 3010536692
- 1054811
- 1020279
- 3015231789
- 3010039400
- 3006017180
- 3005718816
- 3005706667
- 3008262872
- 3009887475
- 2134285
- 3009888740
- 3011683674
- 3009882462
- 3011274144
- 3011534620
- 3013194153
- 3008102042
- 2244478
- 3009973336
- 1645151
- 3004371426
- 3002907620
- 2183744
- 3004358587
- 3009732568
- 3009555447
- 1822565
- 3007539489
- 1720929
- 1018470
- 3005551626
- 3003477135
- 1219655
- 3004976965
- 3027737826
- 3010178296
- 3014302784
- 3006801265
- 3013302242
- 3035366890
- 3009555440
- 3010400367
- 3016090213
- 1833920
- 1424263
- 3008110533
Source Documents#
Other 510(k) Records For Product Code HSX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| K251834 | Persona Partial Knee | Zimmer Biomet | 2025-08-15 |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025-07-24 |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025-07-01 |
| K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024-12-06 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024-10-30 |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024-10-07 |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | 2024-04-04 |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023-03-10 |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022-06-16 |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022-06-02 |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | 2021-12-16 |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021-11-16 |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-10-12 |