# K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek
- Decided: Sep 11, 2024 after 152 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180101: HEALIX ADVANCE KNOTLESS BR Anchor, Medos International SARL (2018) Summary page 7.
- K171114: HEALIX ADVANCE KNOTLESS Anchor, Medos International SARL (2017) Summary page 7.
- K191242: HEALIX ADVANCE SP BIOCOMPOSITE Anchor, Medos International SARL (2019) Summary page 7.
- K182941: HEALIX ADVANCE SP PEEK Anchor, Medos International SARL (2019) Summary page 7.
- K201883: 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor, Medos International SARL (2020) Summary page 7.

## Indications for use
The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows: * Shoulder: Rotator Cuff Repair * Shoulder: Bicep Tenodesis * Shoulder: Deltoid Repair * Elbow: Ulnar Collateral Ligament (UCL) * Elbow: Radial Collateral Ligament (RCL) * Knee: Posterior Oblique * Knee: Medial Collateral Ligament (MCL) * Knee: Lateral Collateral Ligament (LCL) * Knee: liotibial (IT) Band Tenodesis * Knee: Anterior Cruciate Ligament (ACL) Repair * Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair * Knee: Meniscal Root Repair * Foot and Ankle: Achilles Tendon Repair The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK Anchors is indicated as follows: * Shoulder: Rotator Cuff Repair * Shoulder: Bicep Tenodesis * Shoulder: Deltoid Repair * Elbow: Ulnar Collateral Ligament (UCL) * Elbow: Radial Collateral Ligament (RCL) * Knee: Posterior Oblique * Knee: Medial Collateral Ligament (MCL) * Knee: Lateral Collateral Ligament (LCL) * Knee: liotibial (IT) Band Tenodesis * Knee: Anterior Cruciate Ligament (ACL) Repair * Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair * Knee: Meniscal Root Repair * Foot and Ankle: Achilles Tendon Repair * Foot and Ankle: Lateral Stabilization * Foot and Ankle: Medial Stabilization The DePuy Mitek HEALIX ADVANCE SP Biocomposite Anchors is indicated as follows: * Shoulder: Rotator Cuff Repair * Shoulder: Bicep Tenodesis * Shoulder: Deltoid Repair * Elbow: Ulnar Collateral Ligament (UCL) * Elbow: Radial Collateral Ligament (RCL) * Knee: Posterior Oblique * Knee: Medial Collateral Ligament (MCL) * Knee: Lateral Collateral Ligament (LCL) * Knee: liotibial (IT) Band Tenodesis * Knee: Anterior Cruciate Ligament (ACL) Repair * Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair * Knee: Meniscal Root Repair The DePuy Mitek HEALIX ADVANCE SP PEEK Anchors is indicated as follows: * Shoulder: Rotator Cuff Repair * Shoulder: Bicep Tenodesis * Shoulder: Deltoid Repair * Elbow: Ulnar Collateral Ligament (UCL) * Elbow: Radial Collateral Ligament (RCL) * Knee: Posterior Oblique * Knee: Medial Collateral Ligament (MCL) * Knee: Lateral Collateral Ligament (LCL) * Knee: liotibial (IT) Band Tenodesis * Knee: Anterior Cruciate Ligament (ACL) Repair * Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair * Knee: Meniscal Root Repair * Foot and Ankle: Achilles Tendon Repair * Foot and Ankle: Lateral Stabilization * Foot and Ankle: Medial Stabilization

Source page: https://510kreport.com/device/K241010
Methodology: https://510kreport.com/methodology