# K080685: Hiploc Compression Hip Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Aug 15, 2008 after 157 days
- Product code: JDO (Device, Fixation, Proximal Femoral, Implant)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K781389 (1978). 2 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K781389: Biomet Concentric Hex Screw, Biomet, Inc. (1978) Summary page 1.
- K981757: Synthes (Usa) DHS Helix System, Synthes (Usa) (1998) Summary page 1.

## Most influential descendants
- K140018: TSP Hip Fracture Plating System (2014), 1 descendant of its own
- K173826: THP Hip Fracture Plating System (2018), 0 descendants of its own

## Recalls of this device
- Aug 9, 2018 · Class II · Z-3264-2018: HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- Aug 9, 2018 · Class II · Z-3263-2018: HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- Aug 9, 2018 · Class II · Z-3261-2018: HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- Aug 9, 2018 · Class II · Z-3262-2018: HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

## Indications for use
Indications for the HipLOCTM Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

Source page: https://510kreport.com/device/K080685
Methodology: https://510kreport.com/methodology