# K101622: Zimmer Natural Nail System Retrograde Femoral Nails

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 1, 2010 after 114 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: 4 generations back to K970097 (1997). 8 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962561: Supracondylar Intramedullary Nail, Zimmer, Inc. (1996) Summary page 1.
- K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems, Depuy, Inc. (2003) Summary page 1.

## Most influential descendants
- K172114: Zimmer Natural Nail System (2017), 11 descendants of its own
- K142281: Zimmer M/DN Intramedullary Fixation System (2014), 10 descendants of its own
- K200869: Gamma3 System (2020), 9 descendants of its own
- K203819: T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System (2021), 7 descendants of its own
- K181827: Affixus Natural Nail System Humeral Nail (2018), 6 descendants of its own

## Recalls of this device
- Mar 26, 2018 · Class II · Z-1467-2018: Potential failure of sterile packaging seal.
- Mar 26, 2018 · Class II · Z-1469-2018: Potential failure of sterile packaging seal.
- Mar 26, 2018 · Class II · Z-1468-2018: Potential failure of sterile packaging seal.

## Indications for use
The Zimmier 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/K101622
Methodology: https://510kreport.com/methodology