STERILE KIRSCHNER WIRES AND STEINMANN PINS
FDA 510(k) clearance K960385 · decided 1996-03-27
Clearance details
- K-number
- K960385
- Device name
- STERILE KIRSCHNER WIRES AND STEINMANN PINS
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-26
- Decision date
- 1996-03-27
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- HTY
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Depuy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZipToe™ Hammertoe Fusion System (K253325) | Toetal Solutions | 2025-12-29 |
| Impact PEEK Union Nail System (K252657) | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| RONAVIS – FX (FX-001) (K250315) | AIRS, Inc. | 2025-08-01 |
| PediFlex™ Flexible Nail System (K251362) | OrthoPediatrics Corp. | 2025-06-24 |
| Impact PEEK Union Nail System (K250646) | Nvision Biomedical Technologies | 2025-06-11 |
| Biomet Kirschner Wires (K-Wires) (K241014) | Biomet, Inc. | 2024-05-22 |
| OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (K231272) | OSSIO , Ltd. | 2023-12-01 |
| Hammerdesis™ Interphalangeal Fusion System (K231147) | Intelivation | 2023-09-14 |
| OSSIOfiber® Cannulated Trimmable Fixation Nail (K230750) | OSSIO , Ltd. | 2023-09-13 |
| Electro-Spec Steri-Caps (K231905) | Electro-Spec, Inc. | 2023-08-14 |
| Tyber Medical Pin and Wire System (various) (K231339) | Tyber Medical, LLC | 2023-07-06 |
| Hammertoe Truss System (HTS) (K221283) | 4Web Medical, Inc. | 2022-09-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |