# K974016: Cerclage Cable with Hex Button

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Dec 19, 1997 after 58 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dall-Miles Broad Bone Plate: named in the summary without a submission number
- (no number) Pioneer Laboratories Bone Plate with Cerclage Cable: named in the summary without a submission number
- (no number) Bone Plate with Cable: named in the summary without a submission number

## Most influential descendants
- K031162: Smith & Nephew Orthopaedic Cabling System (2003), 10 descendants of its own
- K992617: Hex Button (1999), 10 descendants of its own
- 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
- K203405: EVOS Large Fragment Plating System (2021), 3 descendants of its own

## Indications for use
The Cerclage Cable with Hex Button device is indicated for use where wire, cable, or band cerclage is used in combination with plates. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

Source page: https://510kreport.com/device/K974016
Methodology: https://510kreport.com/methodology