# K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Feb 19, 2009 after 86 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 16 (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). 16 ancestors in all. 39 later devices descend from it; 7 cite it directly. 0 of 56 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 1. - K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series, Zimmer GmbH (2005) Summary page 1. - K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems, Depuy, Inc. (2003) Summary page 1. ## Most influential descendants - K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own - K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own - K091566: Zimmer Natural Nail System Cephalomedullary Nails (2009), 16 descendants of its own - K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (2019), 15 descendants of its own - K172114: Zimmer Natural Nail System (2017), 11 descendants of its own ## Recalls of this device - Apr 28, 2017 · Class II · Z-2599-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. - Jun 17, 2015 · Class II · Z-2060-2015: A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and r - Jul 1, 2009 · Not classified · Z-0376-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0377-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0378-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0381-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0385-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0386-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0375-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0379-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0380-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0382-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0383-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0384-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0387-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be - Jul 1, 2009 · Not classified · Z-0388-2010: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be ## Indications for use The Zimmer NaturalNail 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 Source page: https://510kreport.com/device/K083497 Methodology: https://510kreport.com/methodology