510(k) K221292
- Device
- Uni Knee Resurfacing System
- Applicant
- Overture Resurfacing, Inc.
- 510(k) number
- K221292
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-10
- Date received
- 2022-05-04
- 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
- No
Applicant Contact#
- Contact
- Riley Williams
- Address
- 1617 3rd Ave., #287284 New York NY US 10128 10128
FDA Registration Numbers#
- 1000550978
- 9616680
- 2528981
- 3022142628
- 3014763043
- 2244478
- 1423662
- 3021008900
- 3013194153
- 3016851379
- 3033509898
- 3010400367
- 3008110533
- 3007993775
- 1047843
- 3015398319
- 3002907620
- 1421101
- 3009973505
- 3010331645
- 1043653
- 3012755988
- 1048735
- 3011061242
- 3004371426
- 2249697
- 3008868758
- 1644408
- 2028632
- 2245304
- 3006395932
- 2532027
- 3010287685
- 3017410889
- 3010097171
- 1018470
- 3008262872
- 9616671
- 8043792
- 1057425
- 1818910
- 3000264985
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 3015231789
- 3005144609
- 3010041693
- 3006783837
- 3003998208
- 3010047402
- 3005180920
- 3010375065
- 3005551626
- 1020279
- 3004153240
- 3003541440
- 3011015572
- 1061927
- 3003639920
- 1825034
- 1226544
- 3007539489
- 3009241418
- 3004154314
- 3012523063
- 3013055499
- 1828288
- 1822565
- 3016438694
- 3010536692
- 3009555440
- 3009848551
- 1526534
- 3011187779
- 3004358587
- 3025603301
- 1219655
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 |
| 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 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 |