# K021798: Smith & Nephew Image Guided Surgical Instruments for Hip Applications

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 9, 2002 after 192 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
No predicates in its family tree.
5 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) StealthStation Generation 3: named in the summary without a submission number
- (no number) VectorVision Hip: named in the summary without a submission number
- (no number) VectorVision2: named in the summary without a submission number
- (no number) Image Guided Surgical Instruments for Knees: named in the summary without a submission number
- (no number) Knee Module For the StealthStation System: named in the summary without a submission number

## Most influential descendants
- K033341: Smith & Nephew Image Guided Surgical Instruments for Hip Applications (2004), 4 descendants of its own
- 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 or M R based model or fluoroscopy images of the anatomy. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).

Source page: https://510kreport.com/device/K021798
Methodology: https://510kreport.com/methodology