# K981757: Synthes (Usa) DHS Helix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 17, 1998 after 59 days
- Product code: JDO (Device, Fixation, Proximal Femoral, Implant)
- 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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 LC-DHS: named in the summary without a submission number

## Most influential descendants
- K080685: Hiploc Compression Hip Screw (2008), 2 descendants of its own
- K140018: TSP Hip Fracture Plating System (2014), 1 descendant of its own
- K173826: THP Hip Fracture Plating System (2018), 0 descendants of its own
- K103015: Odrc-Dynamic Hip Screw System (2011), 0 descendants of its own

## Indications for use
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

Source page: https://510kreport.com/device/K981757
Methodology: https://510kreport.com/methodology