INVISIKNOT Ankle Syndesmosis Repair Kit
FDA 510(k) clearance K162996 · decided 2017-06-08
Clearance details
- K-number
- K162996
- Device name
- INVISIKNOT Ankle Syndesmosis Repair Kit
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-27
- Decision date
- 2017-06-08
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- HTN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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| Bolo Button System (K242091) | Fusion Orthopedics | 2024-12-23 |
| TACTIX Vector Syndesmosis System (K243408) | Vilex, LLC | 2024-11-27 |
| EXPERT - Flexible Joint Fixation System (K242311) | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 |
| TACTIX Vector Syndesmosis System (K240035) | Vilex, LLC | 2024-08-01 |
| TENSOR® Suture Button System (K240947) | Globus Medical, Inc. | 2024-06-03 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |