# K200503: ATL Anchors

- Pathway: 510(k) (Traditional)
- Applicant: International Life Sciences
- Decided: Sep 2, 2020 after 184 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193295: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor, Parcus Medical, LLC (2020) Summary page 4.
- K093428: Smith & Nephew Knotless Instability Anchor, Smith & Nephew Endoscopy, Inc. (2009) Summary page 4.

## Most influential descendants
- K260317: Artelon Convenience Kits (2026), 0 descendants of its own
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants of its own

## Recalls of this device
- 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
The ATL 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, Illiotibial 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/K200503
Methodology: https://510kreport.com/methodology