Product code HSX
- Device name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3520
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-08-20 |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-03-12 |
| K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021-01-08 |
| K203099 | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2020-10-27 |
| K202207 | Materialise PKA Guide System | Materialise NV | 2020-10-02 |
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020-03-17 |
| K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Ti... | Zimmer, Inc. | 2020-03-17 |
| K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019-12-05 |
| K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-10-08 |
| K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019-07-25 |
| K191325 | EMPOWR Partial Knee | Encore Medical L.P. | 2019-07-16 |
| K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019-02-11 |
| K183029 | MOTO Partial Knee System | Medacta International S.A. | 2019-01-30 |
| K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-01-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613154557431 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327015621 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015812 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015799 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015782 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015775 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015744 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015720 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015713 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015706 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015683 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015676 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015669 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015652 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015645 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015638 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015614 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015607 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015591 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015553 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015546 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015539 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015522 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015515 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015508 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327015478 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014600 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014570 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014556 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327014549 | Scorpio | Howmedica Osteonics Corp. | 2015-09-24 |