MERETE LOCKING BONE PLATE SYSTEM

K090063 · Merete Medical, Inc. · KTT · Apr 22, 2009 · Orthopedic

Device Facts

• Record ID: K090063
• Device Name: MERETE LOCKING BONE PLATE SYSTEM
• Applicant: Merete Medical, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Apr 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.

Device Story

Merete Locking Bone Plate System consists of contoured, anatomically shaped locking bone plates, 3.0mm and 3.5mm locking screws, and cannulated 3.0mm compression screws. Used by surgeons for internal fixation of small bone fractures, joint fusion, and reconstruction. Device provides mechanical stabilization of bone segments to facilitate healing. Operates via locking mechanism between plate and screws to create stable construct. Used in clinical/surgical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Constructed from titanium alloy Ti-6Al-4V. System includes contoured locking plates and locking/cannulated compression screws. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for adult and pediatric patients requiring fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.

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

• DARCO Locking Plate System (K067808)
• Merete BLP™ Small Fragment Locking Bone Plate System (K063487)
• Merete 3.0 mm and 3.5 mm Locking Screws (K081513)

Submission Summary (Full Text)

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510(k) Submission - Merete Locking Bone Plate

#### 2. 510(k) Summary

| Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102,<br>12247 Berlin, Germany | APR 22 2009 |
|----------------------------|-----------------------------------------------------------------------------------------------------------|-------------|
| FDA Registration Number: | 3002949614 | |
| Contact Person: | Jörg Mietzner<br>Merete Medical, Inc.<br>49 Purchase Street<br>Rye, New York 10580<br>Phone: [phone] | |
| Device Name: | Merete Locking Bone Plate System | |
| Device Classification: | 21 CFR 888.3030 Single/multiple component<br>Metallic bone fixation appliances and accessories | |
| Product Code: | KTT | |
| Proposed Regulatory Class: | Class II | |

#### Predicate Device:

- DARCO Locking Plate System K067808 ।
- Merete BLP™ Small Fragment Locking Bone Plate System K063487 ।
- Merete 3.0 mm and 3.5 mm Locking Screws K081513 ﮯ

## Device Description:

The Merete Locking Bone Plate System consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures, Merete 3.0mm and 3.5mm locking screws and cannulated 3.0mm compression screws. The system is made of titanium alloy Ti-6Al-4V.

#### Intended use:

The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.

## Technological Characteristics:

The components of the Merete Locking Bone Plate System are similar to legally marketed predicate device listed above in that they share similar indications for use, are manufactured from similar materials and incorporate similar technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus. The caduceus is depicted in black, while the text is also in black against a white background.

Public Health Service

Merete Medical, Inc. % Mr. Jorg Mietzner 49 Purchase Street Rye, New York 10580

APR 22 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K090063

Trade/Device Name: Merete Locking Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: January 9, 2009 · Received: January 23, 2009

Dear Mr. Mietzner:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (OS) 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- Mr. Jorg Mietzner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 1. Indications for Use Statement

# Indications for Use

510(k) Number (if known): 长 09 006 3

Device Name: Merete Locking Bone Plate System

Indications for Use:

The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand feet ankles, fingers, and (Division Sign-Off) toes.

# Division of General. I estorative. and Neurological Devices

Prescription Use
(Part 21 CFR 801 Subpart D)

**510(k) Number** K090063

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)