# K062228: Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 8, 2006 after 98 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: 2 generations back to K022126 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033223: Zimmer Ortho Guidance Systems- Hip Instruments, Zimmer, Inc. (2004) Summary page 1.

## Indications for use
Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip orthopedic 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, fluoroscopy images, or digitized landmarks of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to: Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures

Source page: https://510kreport.com/device/K062228
Methodology: https://510kreport.com/methodology