510(k) K222645
- Device
- Treace Medical Concepts (TMC) Implant Fixation System
- Applicant
- Treace Medical Concepts
- 510(k) number
- K222645
- Product code
- JDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-21
- Date received
- 2022-09-01
- Regulation
- 888.3030
- Classification name
- Staple, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brittany Grochala
- Address
- 203 Fort Wade Rd., Suite 150 Ponte Vedra FL US 32081 32081
FDA Registration Numbers#
- 3024021261
- 3014273424
- 3015173212
- 3014262693
- 8010944
- 2029275
- 3010673777
- 3010041499
- 3008650117
- 2244478
- 1423662
- 3010622588
- 3000203391
- 3015974593
- 9610622
- 3020584246
- 3002807314
- 3007503337
- 3013700547
- 3019356409
- 3016851379
- 3027848094
- 3007663067
- 3019269298
- 2320767
- 3033509898
- 3010400367
- 3008110533
- 3032588003
- 3009110133
- 3017196117
- 3014004349
- 3008034554
- 3007993775
- 1047843
- 2936485
- 3002907620
- 3009971621
- 3018094310
- 3012883081
- 3010331645
- 1043653
- 3008749819
- 1048735
- 3009540749
- 3014207283
- 2530154
- 3008868758
- 3030627814
- 2245304
- 2028632
- 2183967
- 3015200653
- 3012470322
- 3011301313
- 1018470
- 3010470577
- 3008951116
- 9617083
- 1824199
- 1219930
- 9710629
- 8043792
- 3004579081
- 3006460162
- 1220477
- 3027339877
- 3015231789
- 3015183635
- 3008812560
- 3015780293
- 3010041693
- 3006783837
- 3012478585
- 3010047402
- 8044102
- 3009812190
- 3010273872
- 3025141
Source Documents#
Other 510(k) Records For Product Code JDR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250712 | Linkt Compression Staple System | Trax Surgical | 2025-05-14 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025-04-11 |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025-01-31 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 |
| K240212 | COGNiTiON™ Staple System | Ortho Solutions UK , Ltd. | 2024-02-23 |
| K232990 | A’TOMIC™ Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | 2023-12-04 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023-10-19 |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023-08-11 |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023-08-09 |
| K231458 | Extremity Staple | Restor3D | 2023-08-03 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 |