# K082770: Zimmer Natural Nail System Tibial Nail - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Dec 11, 2008 after 80 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 15 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K914453 (1992). 14 ancestors in all. 35 later devices descend from it; 8 cite it directly. 0 of 50 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. - K032097: Depuy Ace Versanail Tibial Nail, DePuy Orthopaedics, Inc. (2003) Summary page 1. ## Most influential descendants - 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 - 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 - K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (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 ## Recalls of this device - Jul 30, 2018 · Class II · Z-3246-2018: The item is labeled as an 8.3mm, but it is actually a 12 mm. - 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 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 Source page: https://510kreport.com/device/K082770 Methodology: https://510kreport.com/methodology