# K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Aug 10, 2012 after 155 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: 6 generations back to K970097 (1997). 19 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091566: Zimmer Natural Nail System Cephalomedullary Nails, Zimmer GmbH (2009) Summary page 1.
- K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 1.

## Most influential descendants
- K192312: Zimmer Natural Nail System Cephalomedullary Nails (2019), 4 descendants of its own
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K140601: Flow-Nail (2014), 2 descendants of its own
- K221115: Flow-Nail (2022), 1 descendant of its own
- K181640: X-BOLT Hip Fracture Fixation System (2018), 1 descendant of its own

## Indications for use
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Cephalomedullary nails include: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies Intertrochanteric and subtrochanteric fractures

Source page: https://510kreport.com/device/K120715
Methodology: https://510kreport.com/methodology