# K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System - Pathway: 510(k) (Traditional) - Applicant: Stryker GmbH - Decided: Jul 1, 2020 after 90 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: 6 generations back to K951740 (1995). 27 ancestors in all. 11 later devices descend from it; 3 cite it directly. 0 of 39 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 11. - K131365: T2 Tibial Nailing System, Stryker Trauma AG (2013) Summary page 11. - K081152: T2 Femoral Nail, Howmedica Osteonics Corp. (2008) Summary page 11. - K021744: T2 Femoral Nail, Howmedica Osteonics Corp. (2002) Summary page 11. - K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 11. - K923580: Synthes TI-6AI-7NB Unreamed Femoral Nail, Synthes (Usa) (1993) Summary page 11. - K023267: T2 Supracondylar Nail System, Howmedica Osteonics Corp. (2002) Summary page 11. - K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees, Howmedica Osteonics Corp. (2010) Summary page 11. - K032898: T2 Recon Nail System, Howmedica Osteonics Corp. (2003) Summary page 11. - K101438: T2 Greater Trochanter Nail, Howmedica Osteonics Corp. (2010) Summary page 11. - K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 11. - K020384: T2 Arthrodesis Nail System, Howmedica Osteonics Corp. (2002) Summary page 11. ## Most influential descendants - 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 - K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own - K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own - K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own - K230088: Ankle Truss System (ATS) (2024), 1 descendant of its own ## Indications for use The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: • Open and closed tibial fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Nonunion and malunion The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following: • Open and closed femoral fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Supracondylar fractures, including those with intra-articular extension • Ipsilateral femur fractures • Fractures proximal to a total knee arthroplasty • Fractures distal to hip joint • Nonunions and malunions The T2 Supracondylar Nail System is indicated for: • Open and closed femoral fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Supracondylar fractures including those with intra-articular extension • Fractures distal to total hip prosthesis • Nonunions and malunions The T2 Recon Nail is indicated for: • Subtrochanteric fractures • Intertrochanteric fractures • Ipsilateral neck/shaft fractures • Comminuted proximal femoral shaft fractures • Femoral fixation required as a result of pathological disease • Temporary stabilization of fractures of the femoral shaft – ranging from the femoral neck to the supracondylar regions of the femur. The T2 Greater Trochanter Nail is indicated for long bone fracture fixation, which may include the following: • Open and closed femoral fractures • Pseudarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Ipsilateral femur fractures • Fractures proximal to a total knee arthroplasty • Nonunions and malunions. The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: • Post-traumatic or primary Arthrosis • Previously infected arthrosis (second degree) • Revision of Failed Ankle Arthrodesis • Failed Total Ankle Replacement • Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) • Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle • Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot • Osteoarthritis • Nonunions or Pseudarthrosis of hindfoot and distal tibia • Malunited tibial pilon fracture • Charcot foot • Severe endstage degenerative arthritis • Severe defects after tumor resection • Pantalar arthrodesis The T2 Arthrodesis Nail is intended for long bone internal fixation, which may include the following: • Aseptic failed total knee arthroplasty • Open and closed femoral fractures • Pseudoarthrosis and correction osteotomy • Pathological fractures, impending pathological fractures, and tumor resections • Ipsilateral femur fractures • Failed external fixation, nonunions and malunions • Periarticular fractures where repair is not possible • Knee arthrodesis Source page: https://510kreport.com/device/K200880 Methodology: https://510kreport.com/methodology