# K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

- Pathway: 510(k) (Traditional)
- Applicant: Xiros, Ltd.
- Decided: Aug 26, 2022 after 226 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 14 generations back to K931386 (1993). 126 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 131 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112786: Proseries Bioimplants-Proankle/Procuff, Synovis Orthopedic and Woundcare, Inc. (2011) Summary page 4.
- K192112: FlexBand Plus, International Life Sciences (2019) Summary page 4.
- K111584: Xylos Macro-Porous Surgical Mesh, Xylos Corporation (2011) Summary page 4.

## Most influential descendants
- 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
The Poly-Tape/Infinity-Lock 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 soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons . The Poly-Tape/Infinity-Lock 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 or other tendons. 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/K220091
Methodology: https://510kreport.com/methodology