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The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The U-Blade Lag Screw is also indicated for rotationally unstable fractures.

The Gamma3 System consists of Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screws, end caps, set screws, distal locking screws, and instrumentation. The purpose of this traditional 510(k) is to update and consolidate system indications and intended use, update MR labeling to reflect new testing, update the mechanical testing analysis, and reference Ø5mm IMN Screws System Locking Screws as compatible components. Additional labeling changes were also made, including operative technique consolidation, safety information updates, and the addition of the MR Conditional symbol to package labels.

The indications for use of this internal fixation device include: - Open and closed tibial fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures, and tumor resections - Fractures involving osteopenic and osteoporotic bone - Nonunion and malunion The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System. The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (tibial nails in various diameters, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The adapters and nail holding screws are manufactured from stainless steel. The Targeting Arm Tibia and Adjusting Device Tibia are made of stainless steel. PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers. The Distal Targeting Arm Tibia is made of PEEK with 30% and 50% carbon fibers. The IMN Screws System includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are made of titanium allov (Ti6Al4V ELI) per ASTM F136.

The indications for use of these internal fixation devices include: - Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, 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 - Open and closed femoral fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures and tumor resections - Ipsilateral femur fractures - Fractures proximal to a total knee arthroplasty - Nonunions and malunions - Fractures involving osteopenic and osteoporotic bone The indications for use of this internal fixation device include: - Open and closed tibial fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures, and tumor resections - Fractures involving osteopenic and osteoporotic bone - Nonunion and malunion The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System. The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF. The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices). The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices). The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.

The indications for use of this internal fixation device include: - Open and closed tibial fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures, and tumor resections - Fractures involving osteopenic and osteoporotic bone - Nonunion and malunion The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System. The indications for use of these internal fixation devices include: - Fixation of subtrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaff 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 - Open and closed femoral fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures and tumor resections - Ipsilateral femur fractures - Fractures proximal to a total knee arthroplasty - Nonunions and malunions - Fractures involving osteopenic and osteoporotic bone The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter, compression screw and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The T2 Alpha Tibia Nailing System will be used with the locking screws cleared in K003018 (Titan Tibial Nail) and K172774 (IMN Screws System). Further, End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with T2 Alpha Femur Antegrade GT/PF Nailing System (K172774). The T2 Alpha Tibia Nailing System will be used with the existing instruments previously cleared in K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Tibia Nailing System is intended for use with IMN Screws System and IMN Instruments System. The IMN Screws System includes bone screws (locking screws previously cleared in K172774 and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System. The IMN Instruments System includes distal targeting device femur antegrade previously cleared in K172774 as well as surgical instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System. The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K172774 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments. The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws originally cleared in K003018 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K010801, T2 Femoral Nail System) as well as locking screws previously cleared in K172774 (IMN Screws System) and the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System). Further, it will be used with the existing instruments previously cleared in K172774 (IMN Instruments System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The indications for use of these internal fixation devices include: - Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, 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 - Open and closed femoral fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures and tumor resections - Ipsilateral femur fractures - Fractures proximal to a total knee arthroplasty - Nonunions and malunions - Fractures involving osteopenic and osteoporotic bone The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System. This submission encompasses multiple systems that have similar intended use and will be used together during the surgical procedure. T2 Alpha Femur Antegrade GT/PF Nailing System: The T2 Alpha Femur Antegrade GT/PF Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136 and PEEK. IMN Screws System: The IMN Screws System includes locking screws that are inserted through the intramedullary nail to stabilize the nail-bone construct. The locking screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. IMN Instruments System: The IMN Instruments System includes instruments that support the implantation and extraction of intramedullary nails and screws.

The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization. The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.

The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment. The Stryker SonicAnchor System is intended to be used for suture or tissue fixation in open procedures in the foot, ankle, knee, hand, wrist, elbow and shoulder. The Stryker SonicAnchor is designed only to be inserted with the SonicFusion equipment. Indications Include: Foot/Ankle • Achilles Tendon Repair • Lateral Stabilization • Medial Stabilization • Hallux Valgus Reconstruction • Midfoot Reconstruction • Metatarsal Ligament Repair • Digital Tendon Transfer Shoulder • Acromio-Clavicular Separation Repair • Proximal Deltoid Repair Elbow • Ulnar or Radial Collateral Ligament Reconstruction Knee • Patellar Tendon Repair Hand/Wrist • Scapholunate Ligament Reconstruction • Carpal Ligament Reconstruction • Repair/Reconstruction of Collateral Ligaments

Stryker SonicPin System: The Stryker SonicPin System consists of a sterile bioresorbable pin implant, the SonicFusion equipment and associated accessories intended for the internal fixation of bone fractures and fragments. The pin is made of PLDLLA (Poly(L-lactide-co-D.L-lactide) which has been evaluated for magnetic resonance safety and is implanted using SonicFusion technology which is a process that employs ultrasonic energy to liquefy a polymer and facilitate a fixed interface between the implant and host bone. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool, Direct Depth Gauge. Stryker SonicAnchor System: The Stryker SonicAnchor System consists of a bioresorbable anchor with suture implant, the SonicFusion equipment and associated accessories intended for the fixation of suture or soft tissue to cancellous bone. The implant is comprised of the anchor, made of PLDLLA (Poly(L-lactide-co-D,L-lactide) which has been evaluated for magnetic resonance safety and a Teleflex Force Fiber suture, made of braided ultrahigh molecular weight polyethylene (UHMWPE) and polypropylene (PP) strands. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool.