# K123745: SP2 Femoral Locking Nail, SP2 Tibial Locking Nail

- Pathway: 510(k) (Traditional)
- Applicant: Biomecanica Industria E Comerico DE Productos Orto
- Decided: Mar 25, 2013 after 109 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010801 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp, Stryker (2011) Summary page 1.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 1.

## Indications for use
The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following: * Open and closed femoral fractures * Pseudloarthrosis and correction osteotomy * Pathologic fractures, including those with intra-articular extension * Ipsilateral femur fractures * Fractures proximal to a total knee arthroplasty * Fractures distal to the hip joint * Nonunions and malunions The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following: * Open or closed shaft fractures with a very proximal and very dlistal extent in which locking screw fixation can be obtained * Pseudlarthrosis * Pathologic and impending pathologic fractures * Multi-fragment fractures * Segmental fractures * Proximal or distal non-unions * Corrective osteotomies * Tumor resections * Comminuted fractures with or without bone loss

Source page: https://510kreport.com/device/K123745
Methodology: https://510kreport.com/methodology