510(k) K230653
- Device
- Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ Sy
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K230653
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-04
- Date received
- 2023-03-09
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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
- Tyler Kulcsar
- Address
- 1450 E. Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 2245304
- 3006015326
- 3009173317
- 3009923578
- 3013843055
- 3003541440
- 3005562917
- 3011295718
- 1020279
- 1000200989
- 3007420745
- 1000550978
- 2030624
- 3010220595
- 1530390
- 3014302784
- 3007200272
- 2249615
- 3004450489
- 3004142400
- 1724955
- 1221763
- 3015398319
- 2531477
- 3004153896
- 3011187779
- 1043653
- 3026771806
- 1720929
- 1644408
- 3012491394
- 3013014058
- 3011461101
- 3006946276
- 3005874553
- 1828464
- 1833506
- 3007334927
- 3008572101
- 1818910
- 3009590742
- 3016470314
- 9681465
- 1835444
- 3020703621
- 3019006180
- 3014662844
- 3035366890
- 3008812251
- 3021566676
- 3015167917
- 1218882
- 3006356043
- 3010155661
- 3010846112
- 3002806470
- 3005718816
- 3008421730
- 3007539489
- 3012130008
- 1836357
- 3010462278
- 2528981
- 3009582259
- 1833920
- 1643817
- 3010173425
- 1526534
- 3009973505
- 3008658204
- 3005061536
- 3010856250
- 3019767615
- 3010390570
- 3016438694
- 3030412764
- 3003477135
- 3011170410
- 3008868758
Source Documents#
Other 510(k) Records For Product Code JWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | 2025-11-19 |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | 2025-09-25 |
| K251554 | Materialise TKA Guide System | Materialise NV | 2025-07-14 |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025-07-08 |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical L.P. | 2025-07-02 |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | 2025-05-08 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025-03-24 |