FIXATION PINS
FDA 510(k) clearance K833952 · decided 1984-02-10
Clearance details
- K-number
- K833952
- Device name
- FIXATION PINS
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-16
- Decision date
- 1984-02-10
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HTY
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |