# K210078: Stryker ProCinch Adjustable Loop Device

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Mar 11, 2021 after 58 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: 9 generations back to K904436 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150416: ProCinch Adjustable Loop Device, Stryker Endoscopy (2015) Summary page 4.

## 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 ligament or tendon repair and reconstruction procedures such as Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Patellofemoral Ligament (MPFL), and Posterolateral Corner (PLC).

Source page: https://510kreport.com/device/K210078
Methodology: https://510kreport.com/methodology