# K250395: BioBrace ® RC Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Apr 7, 2025 after 54 days
- Product code: ORQ (Mesh, Surgical, Deployer)
- 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: 13 generations back to K921895 (1992). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241906: BioBrace®  Reinforced Implant, Conmed Corporation (2024) Summary page 5.

## Indications for use
The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair. The Disposable Inserter is intended to facilitate the delivery and positioning of the implant during soft tissue repairs.

Source page: https://510kreport.com/device/K250395
Methodology: https://510kreport.com/methodology