# K990194: Biobutton

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Sep 17, 1999 after 239 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K973758 (1998). 1 ancestor in all.
310 later devices descend from it; 1 cites it directly.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 2.
- (no number) Hewson Ligament Guide and Button: named in the summary without a submission number

## Most influential descendants
- K033717: Transet Fracture Fixation System (2004), 309 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
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Indications for use
The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

Source page: https://510kreport.com/device/K990194
Methodology: https://510kreport.com/methodology