# K092748: Sureshot Tan Nails and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 26, 2010 after 230 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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: 4 generations back to K981529 (1998). 16 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 1.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.
- K040462: Trigen Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2004) Summary page 1.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 1.
- K050226: Asian Intramedullary Hip Screw Nails, Smith & Nephew, Inc. (2005) Summary page 1.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K243364: TRIGEN META-TAN Trochanteric Antegrade Nail (2024), 1 descendant of its own
- K243608: TRIGEN Stable Lock Nut & Washer (2025), 0 descendants of its own
- K123948: China Nails and Accessories (2013), 0 descendants of its own
- K122170: Smith & Nephew, Inc. Intramedullary Nail System Instrumentation (2012), 0 descendants of its own

## Recalls of this device
- Mar 18, 2025 · Class II · Z-1806-2025: Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequ

## Indications for use
SURESHOT Tm TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, SURESHOT TM TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures. SURESHOT Tm TAN Nails and Accessories are for single use only.

Source page: https://510kreport.com/device/K092748
Methodology: https://510kreport.com/methodology