# K022460: Smith & Nephew Image Guided Surgical System for Knee Applications

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 19, 2002 after 24 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 K012937 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012938: Smith & Nephew Image Guided Surgical Instruments for Knee Applications, Smith & Nephew, Inc. (2002)
- K012937: Knee Module for the Stealthstation System, Medtronic Surgical Navigation Technologies (2002)

## Indications for use
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, 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 MR based model or fluoroscopy images of the anatomy.

Source page: https://510kreport.com/device/K022460
Methodology: https://510kreport.com/methodology