# K203794: HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Feb 1, 2021 after 35 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: 14 generations back to K971358 (1997). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183279: HEALIX Ti ANCHOR with DYNACORD, Medos International SARL (2019) Summary page 5.
- K200949: HEALIX ADVANCE Anchor with DYNATAPE Suture, Medos International SARL (2020) Summary page 5.

## Indications for use
The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation in association with postoperative immobilization. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Source page: https://510kreport.com/device/K203794
Methodology: https://510kreport.com/methodology