# K113297: Knotilus Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: T.A.G. Medical Products Corporation, Ltd.
- Decided: Mar 2, 2012 after 115 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: 5 generations back to K961555 (1996). 12 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070882: Stryker Peek Twinloop Tac, Stryker Endoscopy (2007) Summary page 1.

## Most influential descendants
- K242477: Shoulder Soft Tissue Anchors (2025), 0 descendants of its own
- K210498: Betta Link Knotless Implant System (2021), 0 descendants of its own
- K202178: VersaLoop Anchor System (2020), 0 descendants of its own

## Indications for use
The Knotilus'm 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/K113297
Methodology: https://510kreport.com/methodology