Biomet Microfixation Sternal Closure System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111908 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 Biomet Microfixation Sternal Closure System is a device designed to approximate, compress, and rigidly fixate the sternum following open-heart surgery. It is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.
The system consists of metallic bone plates and screws for sternal fixation and is used in surgical settings by surgeons to stabilize chest wall fractures or post-sternotomy sites. It is supplied as a system for use in patients with normal and poor bone quality. Authorizations include FDA 510(k) clearance under product code HWC and K-number K111908.
Frequently asked questions
What is the Biomet Microfixation Sternal Closure System used for?
It is designed to approximate, compress, and rigidly fixate the sternum following open-heart surgery and to stabilize fractures of the anterior chest wall, including sternal fixation after sternotomy and sternal reconstructive procedures, to promote bone fusion.
What components are included in the Biomet Microfixation Sternal Closure System?
The system consists of metallic bone plates and screws specifically engineered for sternal fixation, used by surgeons in surgical settings to stabilize chest wall fractures or post-sternotomy sites.
Is the Biomet Microfixation Sternal Closure System supplied sterile and for single use?
The device data does not specify sterility or single-use status; however, as a metallic implant system intended for surgical fixation, it is typically supplied sterile and designed for single-use implantation, consistent with standard practice for such devices.
What regulatory pathway was used for the Biomet Microfixation Sternal Closure System?
The device received FDA 510(k) clearance under product code HWC with K-number K111908, indicating it was found substantially equivalent to a legally marketed predicate device through a traditional 510(k) submission.
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: Sternal Closure - Zimmer Biomet, BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM (K121302) — FDA 510(k ..., Biomet Microfixation Sternal Closure System (K161896) — FDA 510 (k ..., PDF MICRFIXAIONMAY 1 8 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111908 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Microfixation, Inc
- FDA Applicant
- Biomet Microfixation, Inc.
Sources (1)
- FDA 510(k) K111908 24 fields · synced Sep 26, 2026