# K191483: HEALIX ADVANCE Anchor with DYNA+TAPE Sutures

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Jun 28, 2019 after 24 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: 12 generations back to K971358 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170639: HEALIX ADVANCE Anchor with PERMATAPE Suture, Medos International SARL (2017) Summary page 4.
- K173859: HEALIX ADVANCE Anchor with DYNACORD Suture, Medos International SARL (2018) Summary page 4.

## Indications for use
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular 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, [liotibial Band Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

Source page: https://510kreport.com/device/K191483
Methodology: https://510kreport.com/methodology