# K070167: Endobutton Direct

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Apr 12, 2007 after 84 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 K922559 (1992). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922559: Acufex Endofix Button, Acufex Microsurgical, Inc. (1992) Summary page 1.

## Most influential descendants
- K101616: The Grapplr and Grapplr Extender (2011), 1 descendant of its own
- K142653: G-Lok and G-Lok XL Extender (2014), 0 descendants of its own

## Indications for use
The Smith & Nephew EndoButton Direct Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.

Source page: https://510kreport.com/device/K070167
Methodology: https://510kreport.com/methodology