# K112296: Lateral Button

- Pathway: 510(k) (Traditional)
- Applicant: T.A.G. Medical Products Corporation, Ltd.
- Decided: Dec 1, 2011 after 114 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: 1 generation back to K970423 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970423: Innovasive Roclet Bone Tunnel Augmentation Device, Innovasive Devices, Inc. (1997) Summary page 1.

## Indications for use
The Lateral ButtonTM is intended to protect the suture/bone during transosseous fixation procedures.

Source page: https://510kreport.com/device/K112296
Methodology: https://510kreport.com/methodology