(65 days)
The intended use of the Gamma3® Nail System includes the following:
Trochanteric Gamma3® Nail: The Trochanteric Gamma3® Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.
Long Length Gamma3® Nail: The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.
The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.
The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and femoral shaft fractures and consists of nails, lag screws, locking screws and set screws. The subject device is a line extension to the Gamma3 Nail System previously cleared in 510(k)s K034002 and K032244 to provide additional components and accessories to the system.
This 510(k) Premarket Notification describes a line extension to an existing intramedullary nail system (Gamma3 Nail System). It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a regulatory submission for a medical device and focuses on establishing substantial equivalence to previously cleared predicate devices. Substantial equivalence claims are based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than on new performance studies with specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document. The document primarily serves to inform the FDA that the new components (line extension) are within the scope and safety profile of the already approved Gamma3 Nail System.
§ 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.