# K241651: Affixus Tibial and Antegrade Femoral Nailing System - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Sep 26, 2024 after 111 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 17 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 8 generations back to K970097 (1997). 41 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 44 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 5. - K063570: Biomet Tibial Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 5. - K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails, Zimmer, Inc. (2009) Summary page 5. - K072161: Biomet Femoral Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 5. - K091566: Zimmer Natural Nail System Cephalomedullary Nails, Zimmer GmbH (2009) Summary page 5. - K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System, Zimmer Switzerland Manufacturing GmbH (2023) Summary page 5. ## Most influential descendants - K253566: Affixus Retrograde Femoral Nailing System (2026), 0 descendants of its own - K243907: Affixus Tibial Nailing System - 4mm screws (2025), 0 descendants of its own ## Recalls of this device - Dec 2, 2025 · Class II · Z-0976-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0970-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0971-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0973-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0975-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0967-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0968-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0969-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0972-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0978-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0979-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0983-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0974-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0977-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0980-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0981-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse - Dec 2, 2025 · Class II · Z-0982-2026: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse ## Indications for use The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections. The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections. Source page: https://510kreport.com/device/K241651 Methodology: https://510kreport.com/methodology