# K172114: Zimmer Natural Nail System

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Aug 10, 2017 after 28 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: 5 generations back to K970097 (1997). 18 ancestors in all.
11 later devices descend from it; 2 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)
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails, Zimmer, Inc. (2009) Summary page 5.
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails, Zimmer, Inc. (2010) Summary page 5.

## Most influential descendants
- K200869: Gamma3 System (2020), 9 descendants of its own
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K242247: ARIX Femur Nail System (2025), 1 descendant of its own
- K261043: AUTOBAHN™ Nailing System (2026), 0 descendants of its own
- K252826: ARIX Femur Nail System (2025), 0 descendants of its own

## Indications for use
ANTEGRADE FEMORAL NAILS: The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa nails in the femur 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 RETROGRADE FEMORAL NAILS: The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include: * Compound and simple shaft fractures * Proximal, metaphyseal and distal shaft fractures * Segmental fractures * Closed supracondylar fractures * Severely comminuted supracondylar fractures with articular involvement * Fractures involving femoral condyles * Comminuted fractures * Fractures involving osteopenic and osteoporotic bone * Pathological fractures * Fractures with bone loss * Pseudoarthrosis, non-union, and mal-union * Periprosthetic fractures * Poly trauma patients

Source page: https://510kreport.com/device/K172114
Methodology: https://510kreport.com/methodology