ORTHOPEDIC PLATE SYSTEM

K972219 · Ferguson Medical · HRS · Nov 20, 1997 · Orthopedic

Device Facts

• Record ID: K972219
• Device Name: ORTHOPEDIC PLATE SYSTEM
• Applicant: Ferguson Medical
• Product Code: HRS · Orthopedic
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

Device Story

Orthopedic Plate System consists of stainless steel bone plates in various sizes and configurations. Intended for surgical implantation to stabilize long bone fractures and facilitate long bone reconstructions. Operated by orthopedic surgeons in clinical or hospital settings. Device provides mechanical fixation to support bone healing. No software or electronic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel bone plates; various sizes and configurations; mechanical fixation; non-electronic; non-software.

Indications for Use

Indicated for fixation of long bone fractures and long bone reconstructions in patients requiring orthopedic plate 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

• Howmedica, Compression System (K770128)
• DePuy, Inc. Distribution Center, Multiplicity of Products (K782123)
• Synthes, Synthes Reconstructive Plates "Y" Plates (K792291)
• Warsaw Orthopedic Company, Bone Plate Warsaw Orthopedic (K862224)
• Kirschner Medical Corp., Kirschner Fixation System Small Fragment (K864924)
• Acufex Microsurgical, Inc., Acufex Cannulated Screws, Washers, Bone Plates (K890641)
• Onyx Medical Corp., Broad Self-Compressing Plate (K903252)
• Surgical Implants, Inc., May Plates (K912936)
• Link America, Humerus Schwabe Radius Plates (K914803)
• The Anspach Effort, Inc., Anspach Mini-Plating System (K921338)
• Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K922167)
• Howmedica, Luhr Pan Fixation System (K923861)
• Sofamor Danek Manufacturing, Inc., Reconstruction Plate System (K924085)
• Smith Nephew Richards, Inc., Variable Angular Hold Bone Plate System (K930480)
• Ace Medical, Universal Reconstruction Plate Company (K930592)
• Ace Ltd., Baumer Ortopedia (K930966)
• Onyx Medical Corp., Multiple Fragment Plate (K931687)
• Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K933112)
• Synthes, Volar Distal Radial Plate (K953644)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white.

916-342-4133 FAX: 916-343

NOV 20 1997

27 August 1997

## 510(k) SUMMARY

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

- A . Classification name: Plate, fixation, bone Plate, bone plate, etc. Common/usual name: Orthopedic Plate System Proprietary name:
- B.G. B. Substantial equivalence: Howmedica, Compression System (K770128), DePuy , Inc. Distribution Center, Multiplicity of Products (K782123), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Warsaw Orthopedic Company, Bone Plate Warsaw Orthopedic (K862224), Kirschner Medical Corp., Kirschner Fixation System Small Fragment (K864924), Acufex Microsurgical, Inc., Acufex Cannulated Screws, Washers, Bone Plates (K890641), Onyx Medical Corp., Broad Self-Compressing Plate (K903252), Surgical Implants, Inc., May Plates (K912936), Link America, Humerus Schwabe Radius Plates (K914803), The Anspach Anspach Mini-Plating System Effort, Inc., (K921338), Alphatec Manufacturing, Inc., Alphatec Compression and Reconstruction Plates (K922167), Howmedica, Luhr Pan Fixation System (K923861), Sofamor Danek Manufacturing, Inc., Reconstruction Plate System (K924085), Smith Nephew Richards, Inc., Variable Angular Hold Bone Plate System (K930480), Ace Medical

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Universal Reconstruction Plate Company. Ace Ltd., Baumer Baumer Ortopedia (K930592), J Plates (K930966), Onyx Medical Corp., Multiple Alphatec (K931687), Fragment Plate Manufacturing, Inc., Alphatec Compression and Synthes, (K933112), Reconstruction Plates Volar Distal Radial Plate (K953644).

- The device is an assortment of C. Device Description: various sizes and configurations of stainless steel bone plates.
- The device is intended to be D. Intended use: implanted for use in the fixation of long bone fractures and for long bone reconstructions.
- The Orthopedic E. Technological characteristics: System is a standardly used device Plate consisting of various sizes and configurations of stainless steel bone plates.

Sincerely, FERGUSON MEDICAL

Frank Fergus

Frank Ferguson Official Correspondent (FDA)

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Mr. Frank Ferquson Ferquson Medical 3407 Bay Avenue Chico, California 95973

Re: K972219 Orthopedic Plate System Requlatory Class: II Product Code: HRS Dated: October 10, 1997 October 15, 1997 Received:

## Dear Mr. Ferguson:

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, Drug, 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 against 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation (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. Frank Ferguson

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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510(k) Number (If known): K972219

Orthopedic Plate System Device Name:

Indications For Use:

The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

beall

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________