# K060121: Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip Applications

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 21, 2006 after 63 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033341: Smith & Nephew Image Guided Surgical Instruments for Hip Applications, Smith & Nephew, Inc. (2004) Summary page 1.
- K040368: Vectorvision Hip 3.0, Brainlab AG (2004) Summary page 1.
- K052178: Depuy Cas Hip Instrumentation, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K052213: Navigation SW Hip 3.1 on CI, Brainlab AG (2005) Summary page 1.

## Indications for use
The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).

Source page: https://510kreport.com/device/K060121
Methodology: https://510kreport.com/methodology