(167 days)
The antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to 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 severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.
The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to 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 severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.
The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures with bone loss and bone transport; open and closed fractures; pathologic fractures; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.
The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral fractures, proximal and distal non-unions and malunions and revisions procedures.
The ES trochanteric nail is intended to treat stable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and Trochanteric Nail Systems.
The proposed Arthrex Femoral Nail System is comprised of femoral nails (antegrade, retrograde, supracondylar retrograde), proximal and distal locking screws, end caps, spacer, and washers. All retrograde nails are threaded on the distal end to accept an end cap. The proximal and distal locking screws are comprised of fully threaded, cancellous or cortical screws and partially threaded cancellous screws. The Arthrex Femoral Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136). The Arthrex Femoral Nail System is sold sterile and is single-use.
The proposed Arthrex Tibial Nail System is comprised of tibial nails, proximal and distal locking screws, end caps, and spacer of varying lengths and diameters. The tibial nail contains slots to accept the locking screws. The proximal and distal locking and blocking screws are comprised of fully threaded, cortical screws and partially threaded cannulated cancellous screws. The end caps are designed to prevent bony in-growth in the distal portion of the nail implant. The spacer is provided for proximal locking. The Arthrex Tibial Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM F136). The Arthrex Tibial Nail System is sold sterile and single-use.
The proposed Arthrex Trochanteric Nail System is comprised of trochanteric nails (short, ES [Extended Short], and long), proximal and distal locking screws, and end caps. The trochanteric nails have slots to accept distal and proximal screws. The proximal end of the nail is threaded to accept an end cap. The Arthrex Trochanteric Nail System (nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM conforming to ASTM F138).
The provided FDA 510(k) summary (K230257) for the Arthrex Intramedullary Nails does not contain information related to software or AI/ML components. Therefore, it does not include acceptance criteria, study details, or performance metrics typically associated with such devices.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through:
- Technological Comparison: Highlighting that the intended use, fundamental scientific technology, design, material, sterility, and shelf-life are identical or have minor modifications that do not raise new questions of safety or effectiveness.
- Performance Data for Hardware Components: Detailing tests performed on the physical device components and packaging, such as:
- Packaging validation and 5-year accelerated aging shelf-life testing (conforming to ISO 11607).
- MRI safety testing (force, torque, image artifact, radiofrequency induced heating) in accordance with FDA guidance and ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213).
- Bacterial Endotoxins Test (BET) to ensure pyrogen limit specifications are met (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14).
Therefore, I cannot answer questions 1 through 9 as they pertain to the evaluation of AI/ML or software performance. The device described is a physical medical implant (intramedullary nails) and the clearance is based on its similarity to existing, cleared hardware.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.