# K992617: Hex Button

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Oct 27, 1999 after 84 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: 1 generation back to K974016 (1997). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974016: Cerclage Cable with Hex Button, Pioneer Surgical Technology (1997) Summary page 2.

## Most influential descendants
- K091799: Cable Ready Cable Grip System Cable Button (2009), 7 descendants of its own
- K120772: NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate (2012), 6 descendants of its own
- K210247: OsteoCentric Integrated Hip Fastener System (2021), 1 descendant of its own
- K261271: Cable-Ready® Cable Grip System (2026), 0 descendants of its own
- K261038: Xpert PFP (2026), 0 descendants of its own

## Indications for use
The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone. The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.

Source page: https://510kreport.com/device/K992617
Methodology: https://510kreport.com/methodology