(76 days)
This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.
The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for an external fixation system, which describes the product, its intended use, and compares it to substantially equivalent products. It does not include details about device performance metrics, studies, or clinical trial data as requested in your prompt.
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510(K) Summary of Safety and Effectiveness
R960014
| Submitter: | Orthopaedic Innovations, Inc.825 South 8th Street, Suite 700Minneapolis, MN 55404Telephone: (612) 672-0021Contact: Carolyn M. Steele | Date of Summary: | 12/28/95MAR 18 1996 |
|---|---|---|---|
| Product: | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories - (21 CFR 88.3030) | |
| Common Name: | External Fixation System | ||
| Trade/Proprietary Name: | Practifix External Fixation System | ||
| Substantially Equivalent Products | Hex-Fix External Fixation by Smith and Nephew RichardsDay External Fixation by DePuyAP/ASIF External Fixation System by Synthes | ||
| Description | The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration | ||
| Intended Use: | This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. | ||
| Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects. | |||
| Comparison to Substantial Equivalent Products: | All made of the same types of materials, equivalent in function and design. |
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.