(47 days)
external fixation of fractures and/or the reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
The MINIFIX is a unilateral external fixator designed for use on small bones such as the metacarpal.
I am sorry but this document is discussing a 510(k) summary for a medical device called "MINIFIX", which is an external fixator for small bones. The document describes its classification, substantial equivalence, device description, intended use, and technological characteristics. It does not contain any information about acceptance criteria, study details, sample sizes, ground truth, or expert involvement as requested in your prompt regarding the performance evaluation of a device. Therefore, I cannot extract the requested information from the provided text.
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916-342-4133 FAX: 916-343-454
NOV 27 1996
01 September 1996
K964094 510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Component, traction, A. Classification name: invasive, or pin, fixation, threaded.
Common/usual name: Unilateral mini-fixator, finger fixator, etc.
MINIFIX Proprietary name:
- equivalence: Howmedica Hoffmann B. Substantial Fixation Pin System (K861766), Lima-LTO SEM External Stabilizer (K880282) and Modular others.
- Device description: The MINIFIX is a unilateral C. . external fixator designed for use on small bones such as the metacarpal.
- The MINIFIX is intended for use in D. Intended use: external fixation of fractures and/or the reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
- The MINIFIX device E. Technological characteristics:
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is similar to predicate devices in its design, function, and intended use.
The proposed device is quite simple in its configuration and design, therefore requires a minimum of instrumentation to install.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Frank Feur
Frank Ferguson Official Correspondent
§ 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.