Bone Mulch Screw System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K991298 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bone Mulch Screw System is a Screw, Fixation, Bone (product code HWC) designed for femoral fixation in anterior cruciate ligament (ACL) reconstruction. It consists of titanium alloy screws—available in cannulated and non-cannulated variants—alongside a titanium screw plug and ultra-high-molecular-weight polyethylene (UHMWPE) plug. These components work together to secure graft placement within the bone, ensuring stable fixation during healing. The system is classified under Class II medical devices with special controls, reflecting its role in orthopedic procedures requiring precise bone integration.
This system is supplied as a sterile, single-use orthopedic implant intended for surgical use in accredited operating rooms. It includes cannulated drill bits (e.g., 0.31" (8 mm) and 0.35" (9 mm)) to prepare femoral tunnels before screw insertion. The device is regulated under FDA 510(k) clearance (K991298) and must comply with orthopedic surgical standards. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and its titanium alloy construction ensures compatibility with MRI environments. No reusable components are specified, and all parts are designed for one-time clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Arthrotek/Biomet Tunneloc Bone Mulch Screw System - A-Z Ortho, BONE MULCH SCREW SYSTEM (K991298) — FDA 510(k) | Innolitics, BONE MULCH SCREW SYSTEM (K991298) - FDA 510(k), MODIFICATION TO BONE MULCH SCREW SYSTEM (K993025) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991298 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K991298 24 fields · synced Oct 1, 2026