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#
- 3012491394
- 2183946
- 3009871135
- 3010392243
- 3009760038
- 3009475821
- 1833506
- 2242737
- 1526534
- 3009971621
- 3010400367
- 3018052045
- 3008868758
- 3005581234
- 3003541440
- 3005718816
- 3010120104
- 3007200272
- 3011724582
- 3014273644
- 1220477
- 1835444
- 3010039400
- 3010386387
- 3014644608
- 3008285983
- 3007334927
- 1828288
- 9681258
- 3008658204
- 1450662
- 3009813841
- 3010856250
- 2030624
- 3016470314
- 3003639920
- 3006015326
- 9610612
- 3010531069
- 3034676720
- 3019767615
- 3010047454
- 3004371426
- 3010898856
- 3004976965
- 3005144609
- 1531174
- 3012392319
- 3007366790
- 9617083
- 3014763043
- 3000236920
- 1061927
- 3015516266
- 1424263
- 3016851379
- 3010288357
- 1834331
- 1720929
- 1054811
- 3015207155
- 2134285
- 3014315560
- 3019006180
- 3007516837
- 3002807314
- 3004748528
- 3027484613
- 3014833750
- 3012329926
- 3004153896
- 2249697
- 9614841
- 3006694268
- 3015231789
- 3021566676
- 1218882
- 1000200989
- 3009555447
- 1833986
Source Documents#
Other 510(k) Records For Product Code JWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026-09-11 |
| K262293 | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2026-09-10 |
| K262341 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | 2026-09-08 |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | 2026-09-04 |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | 2026-09-01 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | 2026-07-31 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 |
| 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 |