# K992891: Synthes Cerclage Positioning Pin

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 2, 1999 after 67 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
Longest line of descent: 1 generation back to K953777 (1996). 1 ancestor in all.
12 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953777: Synthes Wire Mount, Synthes (Usa) (1996) Summary page 1.

## 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
- 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
- K210247: OsteoCentric Integrated Hip Fastener System (2021), 1 descendant of its own

## Indications for use
Synthes Cerclage Positioning Pin is intended for use with cerclage monofilament wire and 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 Cerclage Positioning Pin is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.

Source page: https://510kreport.com/device/K992891
Methodology: https://510kreport.com/methodology