# K071135: Depuy CI Hip Instrumentation

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 23, 2007 after 30 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K010612 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052178: Depuy Cas Hip Instrumentation, DePuy Orthopaedics, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K052218: Crono Five and Crono Pca 50, Cane S.R.L. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone preparation during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model of the anatomy. Example orthopaedic procedures for these instruments include, but are not limited to: * Total Joint Replacement (TJR) * Revision Surgery of TJR * Tumor resection and Bone/Joint Reconstruction

Source page: https://510kreport.com/device/K071135
Methodology: https://510kreport.com/methodology