HOFFMANN II ROD TO WIRE COUPLING
FDA 510(k) clearance K053349 · decided 2005-12-09
Clearance details
- K-number
- K053349
- Device name
- HOFFMANN II ROD TO WIRE COUPLING
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-02
- Decision date
- 2005-12-09
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Osteonics Corp.
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 |
|---|---|---|
| MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087) | Synthes (USA) Products, LLC | 2026-06-11 |
| DYNEX® External Fixation Systems (K260900) | Vilex, LLC | 2026-04-17 |
| QuikFix External Fixator: Knee-Spanning Pack (K260112) | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| Excelsior System (K253291) | Blue Ocean Global | 2026-01-20 |
| Hoffmann LRF System (K253202) | Stryker GmbH | 2025-12-19 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |
| Medusa Orthopedics Boa External Fixation System (K252555) | Medusa Orthopedics, LLC | 2025-11-25 |
| The Response Ortho Smart Fixator - Hexapod System (K252625) | Response Ortho Solutions, LLC | 2025-11-20 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) | Amdt Holdings, Inc. | 2025-08-08 |
| Extremity Medical External Fixation System (K251128) | Extremity Medical, LLC | 2025-05-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |