SYNTHES LOCKING HAND PLATES

K092247 · Synthes (Usa) · HRS · Sep 25, 2009 · Orthopedic

Device Facts

• Record ID: K092247
• Device Name: SYNTHES LOCKING HAND PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Locking Hand Plates are intended for fixation of fractures, osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Device Story

Synthes Locking Hand Plates are metallic bone fixation implants designed for small bone surgery. Used by orthopedic surgeons in clinical settings to stabilize fractures, osteotomies, non-unions, replantations, or fusions. Plates provide mechanical support to bone fragments, facilitating healing and alignment, particularly in patients with osteopenic bone. Device is implanted via surgical procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plates. Designed for small bone applications. Material composition and mechanical properties consistent with standard orthopedic fixation hardware.

Indications for Use

Indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an abstract symbol, possibly representing a human figure or a flame.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Synthes (USA) % Ms. Sheri L. Musgnung Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380

SEP 2 5 2009

Re: K092247

Trade/Device Name: Synthes Locking Hand Plates Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS Dated: July 23, 2009 Received: July 28, 2009

Dear Ms. Musgnung

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Ms. Sheri L. Musgnung

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Harbar Buchm

Mark N. Melkerson Director Division of Surgical, Orthopedic, 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):

K092247

Device Name:

Synthes Locking Hand Plates

Indications for Use:

The Synthes Locking Hand Plates are intended for fixation of fractures, osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oputu for mxn
(Division Signee)

(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092247