Suture Wires and Wire Loops
FDA 510(k) clearance K150889 · decided 2015-07-01
Clearance details
- K-number
- K150889
- Device name
- Suture Wires and Wire Loops
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-02
- Decision date
- 2015-07-01
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JDQ
- Device class
- 2
- Regulation number
- 888.3010
- 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 |
|---|---|---|
| Cable-Ready® Cable Grip System (K261271) | Pioneer Surgical Technology, Inc. | 2026-07-16 |
| Stitch Cerclage – Suture Tapes (K243905) | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 |
| Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (K243344) | Arthrex, Inc. | 2025-02-20 |
| Mbrace Cable (K232733) | Medacta International S.A. | 2024-05-03 |
| ACCORD Cable System (K233949) | Smith & Nephew, Inc. | 2024-03-13 |
| VariTrax Sternal CircumFixation System (K232986) | Circumfix Solutions, Inc. | 2024-01-30 |
| Arthrex Radiopaque FiberTape Cerclage sutures (K230976) | Arthrex, Inc. | 2023-08-24 |
| STRETTO™ Cable System (K231333) | Globus Medical, Inc. | 2023-08-04 |
| HS Fiber Cerclage (K220765) | Riverpoint Medical, LLC | 2023-07-26 |
| STERN FIX Sternal Stabilization System (K221795) | Neos Surgery S.L | 2022-10-19 |
| Stern Fix Sternal Stabilization System (K211613) | Neos Surgery S.L | 2022-01-19 |
| EVOS Cabling System (K201497) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 |
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 |