RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
FDA 510(k) clearance K961789 · decided 1996-08-01
Clearance details
- K-number
- K961789
- Device name
- RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-09
- Decision date
- 1996-08-01
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- MAI
- 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 |
|---|---|---|
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| SF Push-in Anchor (K260294) | Surgical Fusion Technologies GmbH | 2026-03-27 |
| OSSIOfiber® Suture Anchor (K254055) | OSSIO , Ltd. | 2026-02-24 |
| Biosteon® Screw (K251680) | Biocomposites, Ltd. | 2026-02-17 |
| BioBrace® Extra-Articular Ligament Augmentation Kit (K252946) | Conmed Corporation | 2025-10-15 |
| OSSIOfiber® Interference Screw (K252022) | OSSIO , Ltd. | 2025-08-19 |
| OSSIOfiber® Suture Anchor (K251309) | OSSIO , Ltd. | 2025-05-27 |
| Knotilus+ Biocomposite Knotless Anchor (K250544) | Stryker Endoscopy | 2025-05-23 |
| Stryker AlphaVent™ Knotless SP Biocomposite Anchor (K250528) | Stryker Endoscopy | 2025-05-21 |
| OSSIOfiber® Suture Anchor 2.5-3.5 mm (K243760) | OSSIO , Ltd. | 2025-04-03 |
| Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (K250526) | Arthrex, Inc. | 2025-03-14 |
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 |