510(k) K953274
- Device
- GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- 510(k) number
- K953274
- Product code
- JWH
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1996-02-05
- Date received
- 1995-07-14
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS L CRAIG
- Address
- 1450 E. Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 3008021110
- 3003541440
- 3004142400
- 1827096
- 1720929
- 3014763043
- 1000286794
- 1000200989
- 3009871135
- 3007353762
- 3010375065
- 1000547811
- 1530390
- 3010173425
- 3022142628
- 2032521
- 3010123256
- 3033796901
- 3005180920
- 3004371426
- 3005652161
- 3009555447
- 3010462278
- 3030412764
- 1221053
- 1645151
- 3005279746
- 3005596372
- 2133928
- 1835251
- 3007200272
- 3025603301
- 3011061242
- 3002907620
- 1832228
- 3006694268
- 3016438694
- 3030446955
- 1221763
- 3010856250
- 3011274144
- 9617840
- 1319660
- 3040391045
- 3006017180
- 3014302784
- 3010039400
- 8010379
- 3012130008
- 3011683674
- 3009732568
- 3013791180
- 3013417938
- 3010363503
- 3007923096
- 1226188
- 9616671
- 3009546990
- 1724955
- 3014252644
- 3010132111
- 3018052045
- 8010916
- 3013176080
- 1835572
- 1220477
- 1219655
- 3010097171
- 3008421730
- 3005874553
- 3010162973
- 1836357
- 1450662
- 3003916006
- 3010120104
- 3036756245
- 1000517406
- 3034676720
- 3010400367
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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