# K102982: Endobutton Direct

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Jan 5, 2011 after 90 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922559 (1992). 3 ancestors in all.
36 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), 35 descendants of its own
- K231857: Arthrex TightRope II (2023), 4 descendants of its own
- K241235: Arthrex TightRope II (2024), 3 descendants of its own
- K211770: R3ACT Stabilization System (2021), 3 descendants of its own
- K173278: ToggleLoc System (2018), 3 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).

Source page: https://510kreport.com/device/K102982
Methodology: https://510kreport.com/methodology