# K060556: Brigit Surgical Device

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 31, 2006 after 151 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: 3 generations back to K002053 (2000). 12 ancestors in all.
128 later devices descend from it; 1 cites it directly.
5 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963256: Neuromate Stereotactic System, Integrated Surgical Systems, S.A. (1997) Summary page 1.
- K043536: Navitrack System - S&N Image Free Knee, Orthosoft, Inc. (2005) Summary page 1.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1.
- K033011: Zimmer Ortho Guidance Systems- Knee Instruments, Zimmer, Inc. (2004) Summary page 1.
- K033223: Zimmer Ortho Guidance Systems- Hip Instruments, Zimmer, Inc. (2004) Summary page 1.
- K052425: Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation, Zimmer, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments. It is indicated for any 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 digitized landmarks 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 • Total or Hemi-Hip Arthroplasty (Primary and Revision) * Minimally Invasive Hip Orthopedic Procedures * Tumor Resection and Bone/Joint Reconstruction • Stabilization or Repair of Pelvic/Femoral Fractures

Source page: https://510kreport.com/device/K060556
Methodology: https://510kreport.com/methodology