# K170280: Smith & Nephew SURESHOT Distal Targeting System V4.0

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 28, 2017 after 88 days
- Product code: OLO (Orthopedic 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: 13 generations back to K010612 (2001). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130748: Smith & Nephew Sureshot Distal Targeting System V3.0, Smith & Nephew, Inc. (2013) Summary page 5.
- K110240: Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1, Smith & Nephew, Inc. (2011) Summary page 6.
- K102967: Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2, Smith & Newphew, Inc. (2010) Summary page 6.
- K100107: Smith & Nephew Sureshot Distal Targeting System V2.0, Smith & Nephew, Inc. (2010) Summary page 6.
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1, Smith & Nephew, Inc. (2009) Summary page 6.

## Indications for use
The Smith & Nephew SURESHOT™ Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT™ Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Source page: https://510kreport.com/device/K170280
Methodology: https://510kreport.com/methodology