# K183232: Double ENDOBUTTON Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew, Inc.
- Decided: Mar 12, 2019 after 112 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 8 generations back to K792022 (1979). 69 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 4.
- K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device, Smith & Nephew Endoscopy, Inc. (2008) Summary page 4.

## Most influential descendants
- K221485: Arthrex FiberTape and TigerTape Cerclage Sutures (2022), 5 descendants of its own
- K232755: Arthrex FiberTape and TigerTape Cerclage Sutures (2023), 2 descendants of its own
- K230976: Arthrex Radiopaque FiberTape Cerclage sutures (2023), 1 descendant of its own
- K243905: Stitch Cerclage – Suture Tapes (2025), 0 descendants of its own
- K243344: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (2025), 0 descendants of its own

## Indications for use
The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).

Source page: https://510kreport.com/device/K183232
Methodology: https://510kreport.com/methodology