Bio-Core Interference Screw
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K042552 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 Bio-Core Interference Screw is a Screw, Fixation, Bone (product code HWC) designed for orthopedic applications. Constructed from a resorbable composite of 85% poly-L-lactic acid (PLLA) and 15% polyglycolic acid (PGA), it provides interference fixation for soft tissue grafts, bone-tendon-bone grafts, or ligament/tendon reconstructions. Its tapered tip and open lattice body facilitate secure placement, while an internal cruciate drive allows packing with autograft or allograft bone.
This device is supplied sterile and intended for single-use in surgical settings. It is classified as a Class II medical device under FDA regulations, with a traditional 510(k) clearance (K042552) granted in 2004. No MRI safety information is specified, and sizes are not detailed in the available data. Storage conditions and additional regulatory authorisations beyond the FDA clearance are not provided.
Frequently asked questions
What is the Bio-Core Interference Screw used for?
The Bio-Core Interference Screw is designed for orthopedic applications to provide interference fixation during soft tissue graft procedures, bone-tendon-bone graft reconstructions, or ligament/tendon repairs. Its tapered tip and open lattice structure help ensure secure placement, while the internal cruciate drive allows for packing with autograft or allograft bone, stabilizing the graft in place.
Is the Bio-Core Interference Screw sterile and single-use?
Yes, the Bio-Core Interference Screw is supplied sterile and intended for single-use in surgical settings. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for one-time clinical application.
What material is the Bio-Core Interference Screw made from?
The screw is constructed from a resorbable composite of 85% poly-L-lactic acid (PLLA) and 15% polyglycolic acid (PGA). This blend allows the device to gradually resorb over time, eliminating the need for removal after healing.
Are there specific sizes or MRI safety details available for the Bio-Core Interference Screw?
The available data does not specify the exact sizes of the Bio-Core Interference Screw or provide MRI safety information. Clinicians should verify compatibility with their imaging protocols and consult manufacturer documentation for precise sizing details.
How is the Bio-Core Interference Screw regulated?
The Bio-Core Interference Screw holds a traditional FDA 510(k) clearance (K042552) under the product code HWC, classified as a Class II medical device. This clearance was granted in 2004 and confirms its substantial equivalence to a predicate device under FDA regulations.
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: BIO-CORE INTERFERENCE SCREW (K042552) — FDA 510(k) | Innolitics, K042552 FDA 510(k) - BIO-CORE INTERFERENCE SCREW | Biomet, Inc., Bio-core Interference Screw - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042552 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K042552 24 fields · synced Oct 1, 2026