Mimix Bone Replacement System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K003494 FDA 510(k)
- FDA Product Code
- LYC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mimix Bone Replacement System is a synthetic bone grafting material designed for cranial defect repair. It consists of a hydroxyapatite-based mixture of tetracalcium and alpha-tricalcium phosphate, formulated to promote osseointegration and structural support in neurosurgical applications, including burr hole and craniotomy site reconstruction.
Supplied as a pre-measured powder in single-use vials, the system is intended for in-office preparation and immediate surgical use. Each package includes mixing tools and patient labels, with three standard sizes available. The device is classified as a Class II medical device under FDA regulations (K003494, 510(k) clearance) and is intended for dental and neurosurgical applications as per regulatory filings.
Frequently asked questions
What types of cranial procedures is the Mimix Bone Replacement System intended for, and how does it support those applications?
The Mimix Bone Replacement System is specifically designed for cranial defect repair, particularly in neurosurgical applications such as burr hole and craniotomy site reconstruction. Its hydroxyapatite-based composition promotes osseointegration, providing both structural support and integration with natural bone, which helps restore the integrity of the skull during these procedures.
How is the Mimix Bone Replacement System supplied, and what does a typical surgical package include?
The Mimix Bone Replacement System is supplied as a pre-measured powder in single-use vials, ensuring sterility and ease of use. Each package includes mixing tools and pre-printed patient labels, allowing for in-office preparation and immediate surgical use without additional contamination risks. This setup streamlines workflow while maintaining compliance with sterile field protocols.
Are there multiple sizes available for the Mimix Bone Replacement System, and how might a clinician determine the appropriate size for a patient?
Yes, the Mimix Bone Replacement System comes in three standard sizes, tailored to accommodate varying cranial defect dimensions. The appropriate size can be determined by preoperative imaging or intraoperative assessment of the defect area, ensuring optimal coverage and structural support during reconstruction.
Is the Mimix Bone Replacement System intended for single-use only, and how should it be stored to maintain its integrity?
The Mimix Bone Replacement System is designed for single-use only, as indicated by its pre-measured vials and sterile packaging. To preserve sterility and effectiveness, it should be stored in a cool, dry place away from direct sunlight, following the manufacturer’s guidelines to prevent degradation before surgical use.
What regulatory pathway was followed for the FDA clearance of the Mimix Bone Replacement System, and how does this affect its use in clinical settings?
The Mimix Bone Replacement System received FDA clearance through a 510(k) Traditional pathway, classified as a Class II medical device under K003494. This clearance confirms its substantial equivalence to a predicate device and ensures compliance with FDA regulations for synthetic bone grafting materials in dental and neurosurgical applications, providing clinicians with confidence in its safety and performance for cranial defect repair.
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: Mimix and Mimix QS Bone Replacement | Zimmer Biomet, PDF Mimix® & Mimix QS Bone Replacement System Brochure, PDF MIMIX QS Bone Replacement System - cirugiadeavanzada.com, PDF MIMIX QS Bone Replacement System - micromedic.se
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003494 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K003494 24 fields · synced Sep 20, 2026