# K980155: Endobutton Continuous Loop

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 1, 1998 after 75 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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). 2 ancestors in all.
347 later devices descend from it; 14 cite it directly.
0 of 350 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 3.
- K952535: Acufex Endobutton Tape, Acufex Microsurgical, Inc. (1996) Summary page 3.

## Most influential descendants
- K984550: Pre-Threaded Endobutton (1999), 310 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM (2006), 143 descendants of its own

## Indications for use
The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Source page: https://510kreport.com/device/K980155
Methodology: https://510kreport.com/methodology