# K033341: Smith & Nephew Image Guided Surgical Instruments for Hip Applications

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 10, 2004 after 329 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 K021798 (2002). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021798: Smith & Nephew Image Guided Surgical Instruments for Hip Applications, Smith & Nephew, Inc. (2002) Summary page 1.

## Most influential descendants
- K052178: Depuy Cas Hip Instrumentation (2005), 2 descendants of its own
- K071135: Depuy CI Hip Instrumentation (2007), 0 descendants of its own
- K053348: Stryker Orthopaedics Rfid Instrumentation (2006), 0 descendants of its own
- K060121: Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip Applications (2006), 0 descendants of its own

## Indications for use
Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical 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 a Long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patents bone, which is generated through acquiring multiple landmarks on the bone surface_ These procedures include but are not limited to, acetabutar cup placement as part of a partial or total hip arthroplasty (primary or revision).

Source page: https://510kreport.com/device/K033341
Methodology: https://510kreport.com/methodology