NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM

K022323 · Osteomedics, Inc. · HRS · Sep 9, 2002 · Orthopedic

Device Facts

• Record ID: K022323
• Device Name: NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
• Applicant: Osteomedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

Device Story

System consists of metallic bone fixation plates and screws; used for wrist arthrodesis and small bone fixation. Plates are convex/concave, 1.0 mm thick, and anatomically contourable. Screws are 2.3 mm diameter, self-tapping, with standard cross-lock or square-lock head designs. Device implanted by surgeons to stabilize bone segments; facilitates fusion and restores function in patients with arthritis, fractures, or bone loss. Provides mechanical support to bone structure during healing process.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Titanium alloy bone fixation system; includes plates (1.0 mm thickness) and self-tapping screws (2.3 mm diameter). Features cross-lock and square-lock screw head designs. Mechanical fixation principle.

Indications for Use

Indicated for wrist arthrodesis and fixation of small bones (radius, carpal bones) in adult and pediatric patients experiencing pain or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, failed wrist fusions, segmental bone loss, rheumatoid arthritis, or tumor resection.

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 9 2002

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## 510 (k) Summary

Device Name: Normed Titanium Rondo Fix Fusion Plate and Screw System

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

Product Code: 87 HRS (21 CFR - 888.3030)

Normed Titanium Rondo Fix Fusion Plate and Screw System consists of a series of convex/concave plates in various shape and length which are attached to the bone using screw fixation. The plates are available in 1.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.3 mm screw diameters will be available in two screw head designs, standard cross-lock and square lock.

Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones. patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

## 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2002 SEP

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

Re: K022323

Trade/Device Name: Normed Titanium Rondo Fix Fusion Plate and Screw 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 15, 2002 Received: July 17, 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.

Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

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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

Singerely yours,

Sincerely yours,

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

6023323 510 (k) Number ( if known): __________________________________________________________________________________________________________________________________________________

Device Name: Normed Titanium Rondo Fix Fusion Plate and Screw System

Indications for use:

Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

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

OR

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

> Prescription use

(Per 21 CFR 801.109)

OVER – THE – COUNTER USE

stut durdy
Division Sign-Off

Bruision of General, Restorative and Neurological Devices

510(k) Number K072323

(Optional Format 1-2-96)