ROGACHEFSKY DISTAL RADIUS PLATES

K981283 · Howmedica, Inc. · HRS · Jun 10, 1998 · Orthopedic

Device Facts

• Record ID: K981283
• Device Name: ROGACHEFSKY DISTAL RADIUS PLATES
• Applicant: Howmedica, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.

Device Story

Distal radius plating system consisting of one volar and two dorsal plates (left/right configurations); modified T-shape; 1.0 mm thickness. Used by orthopedic surgeons in clinical settings for internal fixation of distal radius fractures. Plates feature curved profile to match distal radius anatomy; attached to bone using previously cleared bone screws (Leibinger Radius Reconstruction Plate System). Provides mechanical stabilization of bone fragments to facilitate healing. Available in sterile and non-sterile versions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium alloy (Ti 6Al 4V) conforming to ASTM F136. Design: Modified T-shape plates, 1.0 mm thick, curved profile. Fixation: Bone screws. Sterilization: Available in sterile and non-sterile versions.

Indications for Use

Indicated for internal fixation of distal radius fractures in patients requiring surgical stabilization.

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

• Leibinger Radius Reconstruction Plate System [RRPS] (K961496)
• Alta® Tibial/Upper Extremity Plating System Metaphyseal T Plate (K885250)

Submission Summary (Full Text)

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JUN 1 0 1998

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## 510(k) Summary

Rogachefsky Distal Radius Plates

Device:

For information contact:

John Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Tel: [phone] Fax: [phone]

Date Prepared:

April 16, 1998

Summary:

This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the RRPS Distal Radius Plating System (Howmedica K961496) and the Alta® Tibial/Upper Extremity Plating System Metaphyseal T Plate (Howmedica K885250).

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1998

Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K981283 Trade Name: Rogachefsky Distal Radius Plates Regulatory Class: II Product Code: HRS Dated: April 8, 1998 Received: April 8, 1998

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Mr. John F. Dichiara

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Rogachefsky Distal Radius Plates

Indications for Use:

The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use **__**
(Per 21 CFR 801:109) and/or prescription use, and/or over-the-counter use, and/or over-the-counter use (optional format 1-2-96)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K961203
510(k) Number

. .