METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT

K132226 · Merete Medical GmbH · HRS · Aug 9, 2013 · Orthopedic

Device Facts

• Record ID: K132226
• Device Name: METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
• Applicant: Merete Medical GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

Device Story

Merete BLP™ Small Fragment Locking Bone Plate System is a metallic bone fixation system. Device consists of plates and screws designed for internal fixation of small bone fractures, osteotomies, and non-unions. Used by orthopedic surgeons in clinical/surgical settings. System provides mechanical stabilization of bone fragments to facilitate healing. Output is physical fixation of bone segments. Benefits include stabilization of fractures, particularly in osteopenic bone, to support patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation system (plates and screws). Designed for small bone applications. Class II device (Product Code: HRS).

Indications for Use

Indicated for adult and pediatric patients requiring small bone fracture fixation, including fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, and middle hand/foot bones; specifically indicated for 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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is in black and white.

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

August 9, 2013

Mr. Emmanuel Anapliotis President Merete Medical GmbH Alt-Lankwitz 102 Berlin, 12247 Germany

Re: K132226

Trade/Device Name: Merete BLP™ Small Fragment Locking Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 12, 2013 Received: July 17, 2013

Dear Mr. Anapliotis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Emmanuel Anapliotis

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Erin Jakeith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2: Indications for Use Statement

510(k) Number (if known): K132226

Merete BLPTM Small Fragment Locking Bone Plate System Device Name: The Merete BLP™ Small Fragment Locking Bone Plate System Intended Use: is used for adult and pediatric patients as indicated for small

bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

Prescription Use (Part 21 CFR 801 Subpart D)

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)

## Elizabeth L. Frank -S

Division of Orthopedic Devices

Merete Medical GmbH