# K242187: BioBrace®

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Nov 27, 2024 after 125 days
- Product code: OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K931386 (1993). 118 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203267: The BioBrace Implant, Biorez, Inc. (2021) Summary page 5.
- K230316: FlexBand; FlexPatch; FlexBand Plus, International Life Sciences (2023) Summary page 5.
- K222501: Regeneten Bioinductive Implant, Smith and Nephew, Inc. (2023) Summary page 5.
- K241906: BioBrace®  Reinforced Implant, Conmed Corporation (2024). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K252946: BioBrace® Extra-Articular Ligament Augmentation Kit (2025), 0 descendants of its own

## Indications for use
BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

Source page: https://510kreport.com/device/K242187
Methodology: https://510kreport.com/methodology