NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM

K022231 · Osteomedics, Inc. · HRS · Sep 13, 2002 · Orthopedic

Device Facts

• Record ID: K022231
• Device Name: NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
• Applicant: Osteomedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

Device Story

System consists of titanium plates and 2.7 mm diameter self-tapping titanium bone screws; plates available in various lengths/shapes with 8, 11, or 13 holes; 2.0 mm thickness; contourable to patient anatomy. Used by surgeons in clinical settings for internal fixation of distal radius fractures. Includes hand fixation table for patient support during surgery. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium. Components: Plates (8, 11, 13 holes, 2.0 mm thick) and 2.7 mm diameter self-tapping hex-lock screws (8-38 mm lengths). Form factor: Left/right curved configurations, contourable. Energy source: None (mechanical).

Indications for Use

Indicated for internal fixation of small bones, primarily the distal radius in the forearm, including compression fractures, intra-articular fractures, displaced fractures, and surgical reductions.

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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KU222aBI
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## 510 (k) Summary

Device Name: Normed Distal Radius Reconstruction System

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

Product Code: 87 HRS (21 CFR - 888.3030)

Normed Distal Radius Reconstruction System consists of a series of titanium plates in various shape and length in left and right curved configurations, which are attached to the bone using 2,7 mm diameter titanium bone screws. The plates are available in 8, 11, and 13 holes with 2.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.7 mm screw diameters will be available in hex-lock screw head designs, in sixteen length 8 through 38 mm long in 2mm intervals. A hand fixation table system is also available for the surgeon to rest the injured hand during the surgery.

Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

## Official Contact Person:

Albert Enayati President Osteomedics Inc. 809 Carter Lane Paramus, NJ 07652 Tel: [phone] Fax: [phone] E-mail: [e-mail]

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol resembling a stylized human figure or bird, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 3 2002

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

Re: K022231

Trade/Device Name: Normed Distal Radius Reconstruction System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 8, 2002 Received: July10, 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" (21 CFR 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,

K. Mark A. Millman

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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Indications for use

510 (k) Number ( if known): K022231

Device Name: Normed Distal Radius Reconstruction System.

Indications for use:

Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription use _________________

OVER - THE - COUNTER USE

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N. Milkeren

leneral, Restorative and Neurole

510(k) Number K022231

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