# K191677: MectaTap TI Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 29, 2020 after 219 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The MectaTap 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/K191677
Methodology: https://510kreport.com/methodology