510(k) K170240
- Device
- Truliant Femoral Components
- Applicant
- Exactech Inc
- 510(k) number
- K170240
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-23
- Date received
- 2017-01-26
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Patrick Hughes
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3004142400
- 3018052045
- 3006395932
- 1531174
- 3030446955
- 3008868758
- 1221763
- 3014763043
- 1423662
- 3010009693
- 9613350
- 3003541440
- 3004153240
- 3014252644
- 1218882
- 3009106092
- 3005144609
- 2244478
- 1000517406
- 3013055499
- 3009848551
- 3008544874
- 3002806470
- 3016470314
- 1018470
- 3016851379
- 1644408
- 3006563559
- 1223434
- 2183744
- 3010363503
- 2242737
- 3042172882
- 1226188
- 1000550978
- 3007200272
- 3005718816
- 1530390
- 9617083
- 9616671
- 1834331
- 2030624
- 9614209
- 3007539489
- 3008985661
- 1835572
- 3015516266
- 3010898856
- 3013302242
- 3006487372
- 1529009
- 3009973505
- 9681465
- 3009555447
- 3009882462
- 3007189546
- 1054811
- 1043653
- 3009973336
- 3007913880
- 3010462278
- 3003998208
- 3010047454
- 9680215
- 3012319330
- 2531477
- 3008812251
- 3010537287
- 1643817
- 3005581234
- 3010536692
- 3005360851
- 3010407203
- 3040391045
- 3009555440
- 3004976965
- 3004638532
- 3036756245
- 2025182
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 |
Legacy Summary#
summary
FDA Review#
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