510(k) K212411
- Device
- Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS And Identity Imprint Cruciate Retaining (CR) KRS)
- Applicant
- Conformis Inc.
- 510(k) number
- K212411
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-23
- Date received
- 2021-08-03
- 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
- Kara Johnson
- Address
- 600 Technology Park Dr., 4th Floor Billerica MA US 01821 01821
FDA Registration Numbers#
- 1646498
- 3006563559
- 3014763043
- 3013194153
- 3008985661
- 3033796901
- 3010287737
- 3005279746
- 3010400367
- 3008110533
- 3010047454
- 1047843
- 2032521
- 3026771806
- 1043653
- 3019006180
- 3008868758
- 3002558847
- 1644408
- 2245304
- 3018052045
- 3010097171
- 9617083
- 9680215
- 1220477
- 3009888740
- 3003998208
- 3002806470
- 3042172882
- 1822565
- 3014644608
- 3013791180
- 3010536692
- 3008572101
- 3012392319
- 3006694268
- 3005751028
- 3010288357
- 2134285
- 1828464
- 3004513872
- 3002807310
- 3006801265
- 1834331
- 1054811
- 3002808022
- 1424263
- 3009555447
- 3008102042
- 9614841
- 3010856250
- 3013176080
- 3042508254
- 3035366890
- 1832228
- 9611390
- 3030412764
- 3010314800
- 1529009
- 1833920
- 3009106092
- 3010057495
- 3007675554
- 3012725451
- 3010388970
- 3008812251
- 3020745236
- 3012329926
- 3010039400
- 3010468876
- 3002807112
- 1319660
- 3007353762
- 3004196040
- 3015916578
- 1000550978
- 1218882
- 3006128100
- 8010379
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#
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FDA Review#
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