# K012938: Smith & Nephew Image Guided Surgical Instruments for Knee Applications

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 8, 2002 after 161 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Kinamed Ortho Pilot: named in the summary without a submission number
- (no number) Surgical Navigation Technologies StealthStation: named in the summary without a submission number
- (no number) Surgical Navigation Technologies StealthStation™ System Passive Instrument Option: named in the summary without a submission number
- (no number) Surgical Navigation Technologies StealthStation™ System -ENT Application Addendum: named in the summary without a submission number
- (no number) Surgical Navigation Technologies StealthStation® FluoroNav™ Module: named in the summary without a submission number
- (no number) Surgical Navigation Technologies Indications Modifications for the StealthStation System: named in the summary without a submission number
- (no number) Surgical Navigation Technologies StealthStation Generation 3: named in the summary without a submission number

## Most influential descendants
- K022460: Smith & Nephew Image Guided Surgical System for Knee Applications (2002), 0 descendants of its own

## Indications for use
Image Guided Surgical Instruments for Knee Applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for any medical condition of the knee in which the use of stereotactic surgery may be appropriate, and where 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. Example procedures include, but are not limited to: Orthopedic Procedures: Primary Total Knee Arthroplasty Revison Total Knee Arthroplasty Unicompartmental Knee Replacement

Source page: https://510kreport.com/device/K012938
Methodology: https://510kreport.com/methodology