# K210498: Betta Link Knotless Implant System

- Pathway: 510(k) (Special)
- Applicant: T.A.G. Medical Products Corporation, Ltd.
- Decided: Mar 24, 2021 after 30 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K961555 (1996). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 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.
- K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only, Cayenne Medical, Inc. (2012) Summary page 4.

## Recalls of this device
- May 4, 2023 · Class II · Z-2060-2023: Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injur

## Indications for use
The Betta Link™ Knotless 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/K210498
Methodology: https://510kreport.com/methodology