Cleared Traditional

K203267 - The BioBrace Implant (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203267 · Biorez, Inc. · General & Plastic Surgery device
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Apr 2021
Decision
176d
Days
Class 2
Risk

K203267 is an FDA 510(k) clearance for the The BioBrace Implant. Classified as Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW), Class II - Special Controls.

Submitted by Biorez, Inc. (New Haven, US). The FDA issued a Cleared decision on April 30, 2021 after a review of 176 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biorez, Inc. devices

Submission Details

510(k) Number K203267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2020
Decision Date April 30, 2021
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 114d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

BioVera, Inc.
Robert A Poggie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

All 9
Devices cleared under the same product code (OWW) and FDA review panel - the closest regulatory comparables to K203267.
VersaCoat Tendon Protector (VTP-44G2)
K251655 · Alafair Biosciences · Jul 2025
Rotium
K250021 · Nanofiber Solutions, LLC · Feb 2025
BioBrace®
K242187 · Conmed Corporation · Nov 2024
BioBrace® Reinforced Implant
K241906 · Conmed Corporation · Jul 2024
VersaWrap
K240817 · Alafair Biosciences, Inc. · Jun 2024
SpinMedix Absorbable Fibrous Membrane
K222220 · Celestray Biotech Company, LLC., · Jul 2023