SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
FDA 510(k) clearance K003743 · decided 2001-02-09
Clearance details
- K-number
- K003743
- Device name
- SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2000-12-04
- Decision date
- 2001-02-09
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- MAI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, 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 |
|---|---|---|
| Arthrex Bioabsorbable PushLock Suture Anchors (K262357) | Arthrex, Inc. | 2026-08-07 |
| Arthrex Bioabsorbable PushLock Suture Anchors (K253931) | Arthrex, Inc. | 2026-05-28 |
| 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 |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |