# K200949: HEALIX ADVANCE Anchor with DYNATAPE Suture

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jun 4, 2020 after 56 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 K971358 (1997). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173859: HEALIX ADVANCE Anchor with DYNACORD Suture, Medos International SARL (2018) Summary page 5.
- K183506: HEALIX ADVANCE Anchor with DYNACORD Suture, Medos International SARL (2019) Summary page 5.

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

## Indications for use
The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows: 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 Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K200949
Methodology: https://510kreport.com/methodology