# K183279: HEALIX Ti ANCHOR with DYNACORD

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Feb 21, 2019 after 90 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: 4 generations back to K010673 (2001). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082282: Healix TI Anchor, Depuy Mitek, A Johnson & Johnson Co. (2008) Summary page 4.

## Most influential descendants
- K203794: HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture (2021), 0 descendants of its own

## Indications for use
The HEALIX Ti™ Anchors with DYNACORD™ is intended for: 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; Hip: Capsular repair, Acetabular Labral Repair.

Source page: https://510kreport.com/device/K183279
Methodology: https://510kreport.com/methodology