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BioBrace Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203267

by Biorez, Inc.

Identifiers

510(k) Number
K203267 FDA 510(k)
FDA Product Code
OWW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BioBrace Implant is an absorbable, orthopaedic surgical mesh designed for soft tissue reinforcement. Classified as a surgical mesh under FDA nomenclature, it is intended to provide structural support to tendons and ligaments during healing, aiding in the recovery of soft tissue injuries.

This device is supplied sterile and intended for single-use in orthopaedic procedures, including shoulder, knee, hip, and foot & ankle surgeries. It is regulated under FDA 510(k) clearance (K203267) as substantially equivalent to predicate devices, adhering to the regulatory requirements for absorbable surgical meshes (21 CFR 878.3300). Storage and handling must comply with sterile surgical implant protocols.

Frequently asked questions

What types of orthopaedic surgeries is the BioBrace Implant intended to support during soft tissue healing?

The BioBrace Implant is designed to provide structural support to tendons and ligaments during recovery from soft tissue injuries in procedures involving the shoulder, knee, hip, and foot & ankle. Its absorbable mesh is specifically intended for reinforcement in these orthopaedic surgeries to aid healing.

Is the BioBrace Implant reusable or intended for single-use, and how should it be stored?

The BioBrace Implant is supplied sterile and intended exclusively for single-use in surgical settings. Storage and handling must follow standard sterile surgical implant protocols to maintain its integrity and sterility before use.

What regulatory pathway was followed for the BioBrace Implant’s FDA clearance, and what does this mean for its use?

The BioBrace Implant received FDA clearance through a 510(k) submission (K203267), determined to be *substantially equivalent* to predicate devices under 21 CFR 878.3300. This means it meets regulatory requirements for absorbable surgical meshes and is classified as a Class II device, ensuring it adheres to safety and performance standards for orthopaedic reinforcement.

How is the BioBrace Implant classified, and what medical specialties commonly use it?

The BioBrace Implant is classified as an *absorbable surgical mesh* under FDA nomenclature, specifically for reinforcement of tendons in orthopaedic applications. It is primarily used by surgeons in *general and plastic surgery*, as indicated by its advisory committee classification and intended applications in shoulder, knee, hip, and foot & ankle procedures.

What materials is the BioBrace Implant made from, and how does its absorbable nature affect its use?

While the exact material composition isn’t detailed here, the BioBrace Implant is explicitly described as *absorbable*, meaning it is designed to degrade over time after providing structural support to soft tissues. This feature eliminates the need for long-term removal and aligns with procedures where temporary reinforcement is required during healing.

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: BioBrace Reinforced Bioinductive Implant | CONMED, Biorez Inc. - Specialist in Implant Technology, PDF Biorez, Inc. ℅ Robert Poggie, Ph.D. President BioVera, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biorez, Inc.

Sources (1)

  • FDA 510(k) K203267 24 fields · synced Sep 19, 2026