# K033011: Zimmer Ortho Guidance Systems- Knee Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 12, 2004 after 139 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
- K052425: Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation (2005), 130 descendants of its own
- 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

## Indications for use
Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee 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 or fluoroscopy images of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty (Primary and Revision) Minimally Invasive Knee Orthopedic Procedures

Source page: https://510kreport.com/device/K033011
Methodology: https://510kreport.com/methodology