# K112786: Proseries Bioimplants-Proankle/Procuff

- Pathway: 510(k) (Special)
- Applicant: Synovis Orthopedic and Woundcare, Inc.
- Decided: Oct 25, 2011 after 29 days
- Product code: FTM (Mesh, Surgical)
- 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 K931386 (1993). 100 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 106 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090288: Orthadapt PR, Pegasus Biologics, Inc. (2009) Summary page 1.

## Most influential descendants
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own
- 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
- K230671: Pitch PaSoft Tissue Reinforcement Device (2023), 0 descendants of its own

## Indications for use
PROseriesTM Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. The device is also intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. PROseries Bioimplants are not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

Source page: https://510kreport.com/device/K112786
Methodology: https://510kreport.com/methodology