# K251063: TekBrace Solo Soft Tissue Reinforcement Device

- Pathway: 510(k) (Traditional)
- Applicant: Theramicro
- Decided: May 30, 2025 after 56 days
- Product code: QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament)
- 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). 159 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 162 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, Xiros, Ltd. (2022) Summary page 5.
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, Xiros, Ltd. (2022) Summary page 5.

## Most influential descendants
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), 1 descendant of its own
- K262729: TeKBrace Solo Soft Tissue Reinforcement Device (2026), 0 descendants of its own

## Indications for use
The TeKBrace Solo Soft Tissue Reinforcement Device is a single use device 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. The TeKBrace Solo Soft Tissue Reinforcement Device 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/K251063
Methodology: https://510kreport.com/methodology