# K081205: Synthes (Usa) 5.0MM/7.3MM Crimp Positioning Pins

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 1, 2008 after 63 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Synthes Cerclage Positioning Pin: named in the summary without a submission number
- (no number) Pioneer Surgical Technology Hex Button: named in the summary without a submission number

## Most influential descendants
- K172975: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (2018), 2 descendants of its own
- K243995: Arthrex Humeral Plating System and Cerclage Button (2025), 1 descendant of its own
- K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (2026), 0 descendants of its own

## Indications for use
The Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants. The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.

Source page: https://510kreport.com/device/K081205
Methodology: https://510kreport.com/methodology