# K130595: Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 17, 2013 after 194 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970097 (1997). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082770: Zimmer Natural Nail System Tibial Nail, Zimmer, Inc. (2008) Summary page 1.
- K090596: Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter Antegrade Fem, Zimmer, Inc. (2009) Summary page 1.

## Most influential descendants
- K181184: OIC Intramedullary Nail System (2018), 1 descendant of its own
- K223761: OIC Intramedullary Screw System (2023), 0 descendants of its own

## Recalls of this device
- Nov 5, 2013 · Class II · Z-0586-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Nov 5, 2013 · Class II · Z-0590-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Nov 5, 2013 · Class II · Z-0592-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci

## Indications for use
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: * 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 When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures.

Source page: https://510kreport.com/device/K130595
Methodology: https://510kreport.com/methodology