# K070761: Sanatmetal Nails and Pins

- Pathway: 510(k) (Traditional)
- Applicant: Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.
- Decided: Feb 7, 2008 after 324 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: 3 generations back to K951740 (1995). 14 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails, Smith & Nephew, Inc. (2005) Summary page 1.
- K032722: Trigen Straight Humeral Nail System, Smith & Nephew, Inc. (2003) Summary page 1.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.
- K023115: Ace Versanail, DePuy Orthopaedics, Inc. (2002) Summary page 1.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- K172830: Double Medical Femoral Nail System (2018), 2 descendants of its own
- K253080: AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (2026), 0 descendants of its own
- K253046: HERA Interlocking Intramedullary Nailing System (2026), 0 descendants of its own

## Indications for use
Indications for the Sanatmetal Intramedullary Nails and Pins include traumatologic implants for the intramedullary fixation of fractures of tubular bones (femur, tibia, humerus), nonunions and malunions, i.e. diaphysis fractures, sub-trochanter fractures and femoral sub-trochanter fractures combined with diaphysis fractures, extra- and intraarticular fractures. Sanatmetal Nails and Pins are single use devices.

Source page: https://510kreport.com/device/K070761
Methodology: https://510kreport.com/methodology