# K081098: Endobutton Continuous Loop (CL)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Jul 16, 2008 after 90 days
- Product code: JDR (Staple, Fixation, Bone)
- 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). 54 ancestors in all.
31 later devices descend from it; 6 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070780: Conmed Linvatec XO Button, Conmed Linvatec (2007) Summary page 1.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 1.

## Most influential descendants
- K090923: Parcus Graft Fixation System (2009), 21 descendants of its own
- K133757: GFS II Standard, GFS II Large, GFS Mimi (2014), 16 descendants of its own
- K160655: OrthoButton CL (2016), 9 descendants of its own
- K171060: OrthoButton AL (2017), 8 descendants of its own
- K162198: GFS Ultimate (2016), 8 descendants of its own

## Indications for use
The Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.

Source page: https://510kreport.com/device/K081098
Methodology: https://510kreport.com/methodology