# K091566: Zimmer Natural Nail System Cephalomedullary Nails

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Oct 28, 2009 after 153 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 5 (0 Class I)
- 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.
16 later devices descend from it; 6 cite it directly.
0 of 35 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 1.
- K032367: Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail, Zimmer, Inc. (2003) Summary page 1.
- K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 1.

## Most influential descendants
- K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short (2012), 10 descendants of its own
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), 4 descendants of its own
- 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
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants of its own

## Recalls of this device
- May 7, 2021 · Class II · Z-1792-2021: Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
- May 7, 2021 · Class II · Z-1793-2021: Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
- Oct 10, 2019 · Class II · Z-0337-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Sep 3, 2015 · Class II · Z-0119-2016: In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised 
- Oct 29, 2010 · Not classified · Z-0824-2011: The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining 

## Indications for use
The Zimmer NaturalNail 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/K091566
Methodology: https://510kreport.com/methodology