# K965098: Intramedullary Nail System - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Feb 28, 1997 after 70 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 29 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K962561 (1996). 1 ancestor in all. 75 later devices descend from it; 9 cite it directly. 0 of 77 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 2. - (no number) Kuntscher Nail: named in the summary without a submission number - (no number) Russell-Taylor Intramedullary Nail: named in the summary without a submission number ## Most influential descendants - K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own - K082770: Zimmer Natural Nail System Tibial Nail (2008), 35 descendants of its own - K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own - K032367: Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail (2003), 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 ## Recalls of this device - Apr 28, 2017 · Class II · Z-2597-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. - Apr 28, 2017 · Class II · Z-2596-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2569-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2554-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2572-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2568-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2555-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2559-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2570-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2557-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2556-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2567-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2571-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2561-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2552-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2560-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2553-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2573-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2558-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2551-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2549-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Feb 28, 2017 · Class II · Z-2550-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. - Jan 11, 2016 · Class II · Z-1158-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Jan 11, 2016 · Class II · Z-1140-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Jan 11, 2016 · Class II · Z-1135-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Oct 11, 2013 · Class II · Z-1011-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag - Oct 11, 2013 · Class II · Z-1008-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag - Oct 11, 2013 · Class II · Z-1009-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag - Mar 16, 2004 · Not classified · Z-1004-04: One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation. ## Indications for use Femoral and Tibial Nails The Intramedullary Nail System femoral and tibial nails are indicated for use in fixation of femoral fractures including subtrochanteric, intertrochanteric, comminuted or segmental fractures, as well as fractures with bone loss, proximal and distal fractures, and nonunions. Humeral Nail The humeral Nail is indicated for comminuted fractures, segmental fractures, fractures with bone loss proximal and distal fractures, as well as nonunions, delayed unions, pathological fractures, floating elbow, nerve lesion, and multiple trauma injuries Source page: https://510kreport.com/device/K965098 Methodology: https://510kreport.com/methodology