TRIGEN META-TAN Trochanteric Antegrade Nail

The TRIGEN META-TAN Trochanteric Antegrade Nail is an intramedullary fixation device made from Ti-6Al-4V material, used to treat femur fractures in the proximal third and distal fourth regions. It is available in sizes 30-50 cm in 2 cm increments, is gamma sterilized, and contains proximal holes/slots to accept screws for compression and rotational stability in various fracture types including subtrochanteric, intertrochanteric, and intracapsular fractures.

The device has the same overall technological characteristics and design as the predicate SURESHOT TAN Nails (K092748), including identical material composition (Ti-6Al-4V), similar intramedullary nail design, and equivalent proximal screw-acceptance features. All relevant testing makes reference to existing information previously provided to the agency for the predicate device.

MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013) for META-TAN Nail. Performance bench testing was conducted per applicable ASTM standards, with no clinical testing performed.

Substantial equivalence is established because the subject device is technologically identical to the predicate in design, material, intended use, and performance characteristics. Bench testing demonstrated that the subject device met all required criteria and presented no additional risks compared to the predicate. Since the device is made from the same material, has the same design features, and serves the same indications for fixation of femoral fractures, it is substantially equivalent to the legally marketed predicate device.