NORMED MINI EXTERNAL FIXATOR SYSTEM

K022230 · Osteomedics, Inc. · HRS · Sep 10, 2002 · Orthopedic

Device Facts

• Record ID: K022230
• Device Name: NORMED MINI EXTERNAL FIXATOR SYSTEM
• Applicant: Osteomedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint. The system can be used in both adult and pediatric patients.

Device Story

Unilateral external fixation frame; consists of PEEK swivel clamps, stainless steel distraction/compression rods, PEEK carbon fiber stabilizer rods, and stainless steel half pins. Used by surgeons in clinical settings for small bone stabilization in fingers and toes. Adjustable swivel clamps enable dynamic distraction/compression; simple swivel clamps enable static fixation. Provides mechanical support for bone healing, deformity correction, and joint fusion. Benefits patients by facilitating bone alignment and stabilization in complex fracture or reconstructive cases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Unilateral external fixation frame. Materials: Polyetheretherketon (PEEK) clamps, stainless steel rods/pins, PEEK carbon fiber connecting rods. Rods available in 25, 40, 50, 80 mm lengths. Mechanical fixation principle. Non-powered.

Indications for Use

Indicated for adult and pediatric patients requiring static fixation or dynamic distraction/compression of small bones in fingers and toes. Treats fractures (open, comminuted, infected), nonunions, delayed unions, tumor resections, deformity corrections, burn maintenance, bone grafting defects, and joint fusion.

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.

Submission Summary (Full Text)

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SEP 1 0 2002

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## 510 (k) Summary

Device Name: Normed Mini External Fixator System

Device Identification: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Class II

Product Code: 87 HRS (21 CFR - 888.3030)

Normed Mini External Fixator System is a unilateral (uni-bar) external fixation frame consists of a series of clamps, rods and half pins. The frame is consists of Adjustable Polyetheretherketon (PEEK) Swivel Clamps, PEEK Simple Swivel Clamps, Stainless Steel Distraction/Compression Rods, PEEK Carbon Fiber Smooth Connecting Rods and Stainless Steel Half Pins. The 4mm rods are designed to provide a connecting element for the clamps and are available in 25,40,50 and 80 mm length.

The clamps are manufactured from Polyetheretherketon (PEEK) in one size. The adjustable swivel clamp will be used with stainless steel distraction/compression rods for dynamically applying distraction or compression to the small bones of finger and toe. The simple swivel clamp will be used with Polyetheretherketon PEEK carbon fiber stabilizer rods for static fixator.

## Official Contact Person:

Albert Enavati President Osteomedics Inc. 809 Carter Lane Paramus, NJ 07652 Tel: [phone] Fax: [phone] E-mail: osteomedics(@aol.com

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 0 2002

Mr. Albert Enayati President Osteomedics, Inc. 809 Carter Lane Paramus, New Jersey 07652

Re: K022230

Trade/Device Name: Normed Mini External Fixator System Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulation Class: II Product Code: HRS Dated: June 23, 2002 Received: July 10, 2002

Dear Mr. Enayati:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Albert Enayati

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

. Stypka Plurka

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K002250
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Indications for use

510 (k) Number ( if known):

Device Name: Normed Mini External Fixator System

Indications for use:

Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint. The system can be used in both adult and pediatric patients.

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription use X

(Pcr 21 CFR 801.109)

OR OVER-THE-COUNTER USE

Styp Quorles

(Division Sign-Off) Division of General, Restorative and Neurological Devices

(Optional Format 1-2-96)

510(k) Number K072230

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