# K021815: Smith & Nephew Image Surgical Instruments for Trauma Applications

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 17, 2002 after 136 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Smith & Nephew Image Guided Surgical Instruments for Trauma Applications are intended to be used with the Universal Accessories to assist the surgeon in precisely locating anatomical structures in either open 01 percutaneous procedures. Image Guided Surgical Instruments for Trauma Applications are indicated for use in surgical trauma 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 (femur, tibia, humerus, radius, ulna, fibula): pelvic bone (including acetabular), calcaneus, and talus 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: Spinal procedures and spinal implant procedures such as pedicle screw placement Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation Fracture treatment procedures, such as intramedullary nailing or plating or screwing or external fixation procedures in the tubular bones Additional procedures include: Fracture reduction procedures High Tibia Osteotomy

Source page: https://510kreport.com/device/K021815
Methodology: https://510kreport.com/methodology