# K090596: Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter Antegrade Fem - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Jun 30, 2009 after 117 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: 5 generations back to K970097 (1997). 23 ancestors in all. 3 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. - K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails, Zimmer, Inc. (2009) Summary page 1. - 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 - K130595: Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail (2013), 2 descendants of its own - 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 - Oct 10, 2019 · Class II · Z-0326-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). - Feb 9, 2011 · Not classified · Z-1835-2011: Stryker Orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the Peg Drill to cease functioning. If cold welding of these compo - 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 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 Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral 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/K090596 Methodology: https://510kreport.com/methodology