# K191300: MectaLock Ti Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 12, 2019 after 121 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: 2 generations back to K003984 (2001). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041713: Super Revo Herculine Suture Anchor, Linvatec Corp. (2004) Summary page 4.
- K171640: M-ARS ACL: Anatomic Ribbon Surgery System, Medacta International S.A. (2017) Summary page 4.
- K060664: Fastin RC Anchor, Depuy Mitek (2006) Summary page 4.

## Most influential descendants
- K223582: MectaLock TI Triple Loaded Suture Anchor (2023), 2 descendants of its own
- K230544: SnugFit All-Suture Anchor extension (2023), 1 descendant of its own
- K251933: SnugFit ASA Extension (2025), 0 descendants of its own

## Indications for use
The MectaLock Ti Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure: • Shoulder: cuff rotator repair and biceps tenodesis.

Source page: https://510kreport.com/device/K191300
Methodology: https://510kreport.com/methodology