# K202178: VersaLoop Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: T.A.G. Medical Products Corporation, Ltd.
- Decided: Nov 13, 2020 after 101 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: 10 generations back to K961555 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113297: Knotilus Anchor System, T.A.G. Medical Products Corporation, Ltd. (2012) Summary page 4.
- K181769: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2018) Summary page 4.

## Indications for use
The VersaLoopTm Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

Source page: https://510kreport.com/device/K202178
Methodology: https://510kreport.com/methodology