MINIFIX

K964094 · Ferguson Medical · KTT · Nov 27, 1996 · Orthopedic

Device Facts

• Record ID: K964094
• Device Name: MINIFIX
• Applicant: Ferguson Medical
• Product Code: KTT · Orthopedic
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MINIFIX is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

Device Story

MINIFIX is a unilateral external fixator for small bone stabilization; specifically metacarpals and metatarsals. Device functions as a mechanical fixation system; requires minimal instrumentation for surgical installation. Used by orthopedic surgeons in clinical settings to stabilize fractures or support bone reconstruction. Provides rigid external support to facilitate bone healing. Simple configuration; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Unilateral external fixator for small bones. Mechanical design; no energy source or software. Materials and dimensions consistent with standard orthopedic fixation pins and frames.

Indications for Use

Indicated for patients requiring external fixation for fractures or reconstruction of small bones, specifically metacarpals and metatarsals.

Regulatory Classification

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.

Predicate Devices

• Howmedica Hoffmann Fixation Pin System (K861766)
• Lima-LTO SEM Modular External Stabilizer (K880282)

Submission Summary (Full Text)

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PERGUSON MEDICAL

916-342-4133

FAX: [phone]

NOV 27 1996

01 September 1996

K964094

510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

A. Classification name: Component, traction, invasive, or pin, fixation, threaded.

Common/usual name: Unilateral mini-fixator, finger fixator, etc.

Proprietary name: MINIFIX

B. Substantial equivalence: Howmedica Hoffmann Fixation Pin System (K861766), Lima-LTO SEM Modular External Stabilizer (K880282) and others.

C. Device description: The MINIFIX is a unilateral external fixator designed for use on small bones such as the metacarpal.

D. Intended use: The MINIFIX is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

E. Technological characteristics: The MINIFIX device

2407 New Avenue • Chino California 95073 • USA

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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 Ferguson
Official Correspondent