# K201883: 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Aug 7, 2020 after 30 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: 8 generations back to K961555 (1996). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182941: HEALIX ADVANCE SP PEEK Anchor, Medos International SARL (2019) Summary page 5.
- K191242: HEALIX ADVANCE SP BIOCOMPOSITE Anchor, Medos International SARL (2019) Summary page 5.

## Most influential descendants
- K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (2024), 0 descendants of its own

## Indications for use
The HEALIX ADVANCE SP PEEK Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis Foot/Ankle: Achilles tendon repair The HEALIX ADVANCE SP Biocomposite Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only)

Source page: https://510kreport.com/device/K201883
Methodology: https://510kreport.com/methodology