# K260317: Artelon Convenience Kits

- Pathway: 510(k) (Traditional)
- Applicant: International Life Sciences
- Decided: Apr 9, 2026 after 69 days
- Product code: QWJ (Mesh, Surgical, Polymeric, 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). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230316: FlexBand; FlexPatch; FlexBand Plus, International Life Sciences (2023) Summary page 5.
- K200503: ATL Anchors, International Life Sciences (2020) Summary page 5.

## 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 provide a degradable scaffold that is incorporated into the patient's own tissue. The Twist and FlexBand Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: • Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, llliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. • Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. • Hip: Acetabular labral repair.

Source page: https://510kreport.com/device/K260317
Methodology: https://510kreport.com/methodology