TORUS EXTERNAL FIXATION SYSTEM
FDA 510(k) clearance K925635 · decided 1993-06-01
Clearance details
- K-number
- K925635
- Device name
- TORUS EXTERNAL FIXATION SYSTEM
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-09
- Decision date
- 1993-06-01
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- KTW
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| PK High Tibial Osteotomy Correction System (K182285) | Paonan Biotech Co., Ltd. | 2019-06-20 |
| AOS Anterolateral Proximal Humeral Plate (K171606) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 |
| Phantom Small Bone Intramedullary Nail System (K170693) | Paragon 28, Inc. | 2017-06-19 |
| AOS Anterolateral Proximal Humeral Plate (K160409) | Advanced Orthopaedic Solutions, Inc. | 2016-03-15 |
| ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541) | Orthofix Srl | 2012-09-20 |
| AOS PROXIMAL HUMERAL PLATE (K080590) | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 |
| SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (K080109) | Synthes (Usa) | 2008-03-20 |
| ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (K062920) | Orthofix Srl | 2006-11-13 |
| LEFORTE SYSTEM BONE PLATE (K023360) | Jeil Medical Corporation | 2002-10-25 |
| REPROCESSED EBI EXTERNAL FIXATION DEVICES (K012645) | Alliance Medical Corp. | 2002-06-24 |
| REPROCESSED EXTERNAL FIXATION DEVICE (K012634) | Alliance Medical, Inc. | 2002-06-24 |
| SYNTHES LCP PROXIMAL HUMERUS PLATES (K011815) | Synthes (Usa) | 2001-09-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |