Cleared Traditional

K250395 - BioBrace ® RC Delivery System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250395 · Conmed Corporation · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
54d
Days
Class 2
Risk

K250395 is an FDA 510(k) clearance for the BioBrace ® RC Delivery System. Classified as Mesh, Surgical, Deployer (product code ORQ), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on April 7, 2025 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmed Corporation devices

Submission Details

510(k) Number K250395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2025
Decision Date April 07, 2025
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORQ Mesh, Surgical, Deployer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair).
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 Orthopedic devices follow this clearance model.