# K150416: ProCinch Adjustable Loop Device

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Apr 17, 2015 after 58 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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 K904436 (1990). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) Summary page 4.

## Most influential descendants
- K210078: Stryker ProCinch Adjustable Loop Device (2021), 0 descendants of its own

## Indications for use
The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-to-bone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

Source page: https://510kreport.com/device/K150416
Methodology: https://510kreport.com/methodology