Cleared Traditional

BioBrace?

K242187 · Conmed Corporation · Orthopedic

Nov 2024

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K242187 is an FDA 510(k) clearance for the BioBrace?, a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on November 27, 2024, 125 days after receiving the submission on July 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K242187 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2024
Decision Date	November 27, 2024
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.