SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES

K974908 · Synthes (Usa) · HRS · Mar 18, 1998 · Orthopedic

Device Facts

• Record ID: K974908
• Device Name: SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Mar 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 2.7 mm Reconstruction Plates are intended for distal humerus fractures.

Device Story

Synthes 2.7 mm Reconstruction Plates are stainless steel bone fixation implants used for distal humerus fractures. The plates are available in lengths ranging from 48 mm to 192 mm and are designed to be contoured using bending irons to fit the patient's anatomy. The device is provided sterile. It is intended for use by surgeons in a clinical or surgical setting to stabilize bone fractures, facilitating healing through internal fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Stainless steel. Form factor: Reconstruction plates, 2.7 mm thickness, lengths 48 mm to 192 mm. Sterilization: Provided sterile. Mechanical: Contoured via bending irons.

Indications for Use

Indicated for patients with distal humerus fractures.

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

• Synthes 2.7 mm Reconstruction Plates (K974908)

Submission Summary (Full Text)

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SYNTHES
MAR 18 1998

K974908

Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]

Synthes (USA) SUBMITTER: 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Kevin J. O'Connell

Plate, Fixation, Bone COMMON OR USUAL

21 CFR, Section: 888.3030 CLASSIFICATION CODE:

Synthes 2.7 mm Reconstruction Plates PREDICATE DEVICE:

DESCRIPTION:

NAME:

Synthes 2.7 mm Reconstruction Plates are used with 2.7 mm Syllules 2.7 min Reconbilable in lengths from 48 mm Cortex Serews: "The places oured with bending irons. The plates to 192 film and can be connects steel and are available as sterile.

Intended for distal humerus fractures. INTENDED USE:

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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 stylized eagle symbol with three curved lines representing the eagle's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 1998

Mr. Kevin J. O'Connell Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

K974908 Re: Synthes Sterile 2.7mm Reconstruction Plates Regulatory Class: II Product Code: ਮਝੜ Dated: December 30, 1997 Received: December 31, 1997

Dear Mr. O'Connell:

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 : regulations affecting your device can be found in the Code of Federal Regulations, 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 Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.

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Page 2 - Mr. Kevin J. O'Connell

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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,

Kinnell J. Taylor

/ - Celia 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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small registered trademark symbol is located to the upper right of the word.

SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone [phone]

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Page _________________________________________________________________________________________________________________________________________________________________________

K974908 510(k) Number (if known):

Synthes (USA) Sterile 2.7 mm Reconstruction Plates____________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for use:

The Synthes 2.7 mm Reconstruction Plates are intended for distal humerus fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Russell P. Ayon

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

Original Instruments and Implants of the Association for the Study of Internal Fixation-AO/ASIF