# K230316: FlexBand; FlexPatch; FlexBand Plus

- Pathway: 510(k) (Traditional)
- Applicant: International Life Sciences
- Decided: May 26, 2023 after 109 days
- Product code: OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931386 (1993). 100 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192112: FlexBand Plus, International Life Sciences (2019) Summary page 4.
- K151083: BioBridge Collagen Matrix, Fibralign Corporation (2016) Summary page 4.

## Most influential descendants
- K242187: BioBrace® (2024), 1 descendant of its own
- K260317: Artelon Convenience Kits (2026), 0 descendants of its own
- K252946: BioBrace® Extra-Articular Ligament Augmentation Kit (2025), 0 descendants of its own

## Recalls of this device
- Feb 6, 2026 · Class II · Z-1555-2026: Augmentation devices failed bacterial endotoxin testing.
- Feb 6, 2026 · Class II · Z-1554-2026: Augmentation devices failed bacterial endotoxin testing.
- Feb 6, 2026 · Class II · Z-1556-2026: Augmentation devices failed bacterial endotoxin testing.

## Indications for use
FlexBand®, FlexPatch®, and FlexBand® Plus are intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. FlexBand®, FlexPatch®, and FlexBand® Plus are also 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 tendons, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. FlexBand®, FlexPatch®, and FlexBand® Plus is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendons, 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 tendon repair. The products reinforce soft tissue and provides a degradable scaffold that is incorporated into the patient’s own tissue.

Source page: https://510kreport.com/device/K230316
Methodology: https://510kreport.com/methodology