# K100107: Smith & Nephew Sureshot Distal Targeting System V2.0

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 23, 2010 after 40 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010612 (2001). 28 ancestors in all.
75 later devices descend from it; 6 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1, Smith & Nephew, Inc. (2009) Summary page 1.

## Most influential descendants
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates (2011), 69 descendants of its own
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (2017), 12 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own

## Recalls of this device
- Oct 15, 2010 · Not classified · Z-0411-2011: Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.

## 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 intramedultary nails in which the use of stereotactic surgery may be appropriate.

Source page: https://510kreport.com/device/K100107
Methodology: https://510kreport.com/methodology