510(k) K122239
- Device
- FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
- Applicant
- ENCORE MEDICAL, L.P.
- 510(k) number
- K122239
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-04-11
- Date received
- 2012-07-27
- 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
- TEFFANY HUTTO
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
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 |
Legacy Summary#
summary
FDA Review#
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