# K984550: Pre-Threaded Endobutton

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 1, 1999 after 69 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: 2 generations back to K922559 (1992). 4 ancestors in all.
310 later devices descend from it; 2 cite it directly.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933948: Acufex Endobutton System, Acufex Microsurgical, Inc. (1994) Summary page 1.
- K952535: Acufex Endobutton Tape, Acufex Microsurgical, Inc. (1996) Summary page 1.
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K033838: Titanium Toggle Button (S) (2004), 97 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Indications for use
The Pre-Threaded EndoButton is used for fixation of tendons and ligaments during orthopedic reconstructive procedures such as Anterior Cruciate Ligament (ACL) Reconstruction

Source page: https://510kreport.com/device/K984550
Methodology: https://510kreport.com/methodology