# K033223: Zimmer Ortho Guidance Systems- Hip Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 18, 2004 after 135 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: 1 generation back to K022126 (2003). 1 ancestor in all.
133 later devices descend from it; 3 cite it directly.
5 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022126: Catheter Introducer for the Stealthstation System, Medtronic Surgical Navigation Technologies (2003) Summary page 1.

## Most influential descendants
- K060556: Brigit Surgical Device (2006), 128 descendants of its own
- K092239: Rosa Surgical Device, Model Rosa 1.1 (2009), 127 descendants of its own
- K101791: Rosa Surgical Device (2010), 126 descendants of its own
- K151511: ROSA Spine (2016), 109 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own

## Indications for use
Zimmer Ortho Guidance Systems Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic 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 or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to: Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or Repair of Pelvic/Femoral Fractures

Source page: https://510kreport.com/device/K033223
Methodology: https://510kreport.com/methodology