# K213109: Auxilock Draw Tight Suture-Based Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Aug 22, 2022 after 332 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K911837 (1991). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122805: Parcus Draw Tight 1.8MM Single-Loaded Suture Anchor, Parcus Medical, LLC (2013) Summary page 5.

## Indications for use
The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair. Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle Lateral Stabilization, Medial Stabilization, Mid foot 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, Triangular Fibrocartilage Complex Tear.

Source page: https://510kreport.com/device/K213109
Methodology: https://510kreport.com/methodology