# K192312: Zimmer Natural Nail System Cephalomedullary Nails

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Oct 11, 2019 after 46 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: 7 generations back to K970097 (1997). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 25 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 4.
- K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short, Zimmer GmbH (2012) Summary page 4.

## Most influential descendants
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (2025), 0 descendants of its own
- K230512: Gamma4 System (2023), 0 descendants of its own
- K222309: Gamma4 System (2022), 0 descendants of its own

## Indications for use
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for 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/K192312
Methodology: https://510kreport.com/methodology