# K252946: BioBrace® Extra-Articular Ligament Augmentation Kit

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Oct 15, 2025 after 30 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K931386 (1993). 192 ancestors in all.
No later device cites it as a predicate yet.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K244025: Argo Knotless GENESYS Anchor, Conmed Corporation (2025) Summary page 5.
- K240090: Argo Knotless GENESYS Anchor, Conmed Corporation (2024) Summary page 6.
- K242187: BioBrace®, Conmed Corporation (2024) Summary page 6.

## Indications for use
The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament surgical procedures. The Argo Knotless® GENE SYS TM Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period . The BioBrace® Reinforced Biolnductive Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors during knee repair surgery including reinforcement of patellar ligament, medial collateral ligament, lateral collateral ligament or other knee extra-articular ligaments. It is not intended to replace normal body structures or provide the full mechanical strength to the repair. 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.

Source page: https://510kreport.com/device/K252946
Methodology: https://510kreport.com/methodology