# K203267: The BioBrace Implant

- Pathway: 510(k) (Traditional)
- Applicant: Biorez, Inc.
- Decided: Apr 30, 2021 after 176 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: 11 generations back to K921895 (1992). 38 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121216: STR Graft, Soft Tissue Regeneration, Inc. (2012) Summary page 4.

## Most influential descendants
- K241906: BioBrace®  Reinforced Implant (2024), 3 descendants of its own
- K242187: BioBrace® (2024), 1 descendant of its own
- K252946: BioBrace® Extra-Articular Ligament Augmentation Kit (2025), 0 descendants of its own
- K250395: BioBrace ® RC Delivery System (2025), 0 descendants of its own

## Indications for use
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. 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/K203267
Methodology: https://510kreport.com/methodology