# K051181: Custom-Hip Tool

- Pathway: 510(k) (Special)
- Applicant: Orthopedic Sciences, Inc.
- Decided: May 23, 2005 after 14 days
- Product code: HRS (Plate, Fixation, Bone)
- 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
Longest line of descent: 4 generations back to K850886 (1985). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022139: Hip Tool Implant, Orthopedic Sciences, Inc. (2002) Summary page 1.

## Indications for use
The Custom-Hip ToolTM is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

Source page: https://510kreport.com/device/K051181
Methodology: https://510kreport.com/methodology