Minimally Constrained Elbow Prosthesis
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K003253 FDA 510(k)
- FDA Product Code
- JDC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3150 FDA 510(k)
- Regulation Number
- 888.3150 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Minimally Constrained Elbow Prosthesis is a constrained, cemented elbow joint replacement designed to restore function and stability in patients with severe elbow arthritis or trauma. It consists of metal components, typically cobalt-chromium-molybdenum alloys, paired with an ultra-high molecular weight polyethylene bushing to facilitate smooth articulation and load-bearing within the elbow joint. This device is intended for surgical implantation to replace a damaged or dysfunctional elbow, providing constrained motion to enhance joint stability while minimizing stress on surrounding tissues.
This prosthesis is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under product code JDC as a Class II device under FDA regulations, with clearance granted via a 510(k) submission (K003253). The device requires cement fixation during implantation and is not MRI-safe due to its metallic components. Multiple sizes and configurations are available to accommodate varying patient anatomies, and sterile packaging ensures readiness for intraoperative use. No additional regulatory approvals beyond the FDA 510(k) clearance are stated in the device data.
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: BIOMET'S MINIMALLY CONSTRAINED ELBOW (K003253) - Innolitics, K003253 - BIOMET'S MINIMALLY CONSTRAINED ELBOW | FDA 510(k), BIOMET'S MINIMALLY CONSTRAINED ELBOW - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003253 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K003253 24 fields · synced Oct 1, 2026