# K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail - Pathway: 510(k) (Traditional) - Applicant: I.T.S. GmbH - Decided: Mar 7, 2014 after 169 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K000684 (2000). 70 ancestors in all. 10 later devices descend from it; 4 cite it directly. 0 of 81 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K970097: Proximal Femoral Nail (PFN) System, Synthes (Usa) (1997) Summary page 1. - K954856: Cannulated Femoral Nail, Synthes (Usa) (1996) Summary page 1. - K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series, Zimmer GmbH (2005). Our reading of the summary gave K093270, FDA’s number for Powder-Free Vinyl Patient Examination Gloves (Tangshan Excellence Glove Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer - Sirus IM Femur Nail System”. - K032898: T2 Recon Nail System, Howmedica Osteonics Corp. (2003) Summary page 1. - K051624: T2 Recon Nail System, Howmedica Osteonics Corp. (2005) Summary page 1. - K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees, Howmedica Osteonics Corp. (2010) Summary page 1. - K072161: Biomet Femoral Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 1. - K962047: Titanium Cannulated Tibial Nail (TI CTN), Synthes (Usa) (1996) Summary page 1. - K082770: Zimmer Natural Nail System Tibial Nail, Zimmer, Inc. (2008) Summary page 1. - K021027: S2 Tibial Nail, Howmedica Osteonics Corp. (2002) Summary page 1. - K011622: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws, Howmedica Osteonics Corp. (2001) - K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 1. - K063570: Biomet Tibial Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 1. - K080706: Connexx Locking Tibia Nail, I.T.S. Implantat-Technologie-Systeme GmbH (2008) Summary page 1. - K080184: Distal Humeral Plates with Angular Stability, I.T.S. Implantat-Technologie-Systeme GmbH (2008) Summary page 2. - K120807: Synthes Multiloc Humeral Nailing System, Synthes USA Products, LLC (2012) Summary page 2. - K032722: Trigen Straight Humeral Nail System, Smith & Nephew, Inc. (2003) Summary page 2. - K042396: T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 2. - K920666: Intramedulary Fixation Rod, Acu Med, Inc. (1992) Summary page 2. - K951673: Rod, Fixation, Intramedullary and Accessories, Acu Med, Inc. (1995) Summary page 2. - K951740: Intramedulary Fixation Rod, Acu Med, Inc. (1995) Summary page 2. ## Most influential descendants - K161327: Syntec Humeral Nail System (2017), 3 descendants of its own - K181296: Syntec Femoral Nail System (2019), 2 descendants of its own - K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw (2014), 2 descendants of its own - K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own - K170972: Apex Tibial Nailing System (2017), 1 descendant of its own ## Indications for use The intended use of the LT.S. WW NIl Systems isto stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories: TheLiT.S. CEN - Cannuleted Femur Nail System is indicated for use in long bone femur fracture fixation which include: Open and closed femur shaft fractures: lntertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, mal-union and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use. The LT.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include: Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comnminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss. The system is not for spinal use. The i.T.S. CHN - Cannuleted Humerel Nail System is indicated for use in long bone humerus fracture fixation which include: Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgus-impacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft: Pseudloarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and: Pathological and impending pathological fractures. The system is not for spinal use. Source page: https://510kreport.com/device/K132945 Methodology: https://510kreport.com/methodology