Hoffmann 3 Modular External Fixation System
510(k) K121252
Hoffmann 3 Modular External Fixation System is a Class II device made by Stryker Corp., cleared under FDA 510(k) K121252 on 25 Jul 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121252 | Date25 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K121252
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KTT
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K121252
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| APEX 5026-8-120 | 5026-8-120 / 5026-8-120 | 07613252442783 | Length 5.0 mm | On the market |
| HOFFMANN 4922-9-940S | 4922-9-940S / 4922-9-940S | 04546540716187 | — | On the market |
| HOFFMANN 4922-9-941S | 4922-9-941S / 4922-9-941S | 07613327008005 | — | On the market |
Similar devices
Other devices filed under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).
- MULTIDIRECTIONAL SCREW 8163-35-075 816335075 by Biomet Orthopedics, Inc.
- A.L.P.S.® 8561-35-054 856135054 by Biomet Orthopedics, Inc.
- HOFFMANN 4921-0-015 by Stryker GmbH
- Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 99-50-10300 by ORTHOFIX SRL
- GLIDING NAIL by Encore Orthopedics, Inc.
- HOFFMANN 4922-2-320 by Stryker GmbH
- XtraFix® 00-5200-010-01 by Zimmer, Inc.
- STEALTH FUSION SYSTEM, MODEL RR 1000 by R&R Medical, Inc.
- Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 99-50-10450CE by ORTHOFIX SRL
- NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER by NUTEK Orthopaedics, Inc