# K230544: SnugFit All-Suture Anchor extension

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Apr 17, 2023 after 48 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: 11 generations back to K792022 (1979). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203485: SnugFit All-Suture Anchor, Medacta International S.A. (2021) Summary page 4.
- K193461: MectaLock All-Suture Anchors, Medacta International S.A. (2020) Summary page 4.
- K223582: MectaLock TI Triple Loaded Suture Anchor, Medacta International S.A. (2023) Summary page 4.

## Most influential descendants
- K251933: SnugFit ASA Extension (2025), 0 descendants of its own

## Indications for use
- MectaLock All-Suture Anchor The MectaLock All-Suture anchor is intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures: - Hip: acetabular labral repair - Shoulder: glenoid labrum repair; cuff rotator repair - SnugFit All-Suture Anchor The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures: - Hip: acetabular labral repair - Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

Source page: https://510kreport.com/device/K230544
Methodology: https://510kreport.com/methodology