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 Description

The Merete Locking Bone Plate System II consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for Merete 3.0mm and 3.5mm locking screws (K081513) and cannulated 3.0mm compression screws (K090063). The system is made of titanium alloy Ti-6Al-4V and unalloyed titanium.

AI/ML Overview

This document is a 510(k) summary for the Merete Locking Bone Plate System II. It describes a medical device, specifically a bone plate system, and its intended use. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.

The document focuses on:

Identifying the device and its manufacturer.
Listing predicate devices to establish substantial equivalence.
Describing the device's materials and technological characteristics (stating they are similar to predicate devices).
Stating its intended use (fixation of fractures, revision procedures, etc., in small bones).
Providing FDA correspondence regarding its 510(k) clearance.

Therefore, I cannot provide the requested table and study details as they are not present in the given input.

Summary

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2. 510(k) Summarv

Submitted by:	Merete Medical GmbHAlt Lankwitz 102,12247 Berlin, Germany	DEC - 3 2010
FDA Registration Number:	3002949614
Contact Person:	Emmanuel AnapliotisMerete Medical, Inc.49 Purchase StreetRye, New York 10580Phone: 914 967 1532
Device Name:	Merete Locking Bone Plate System II
Device Classification:	21 CFR 888.3030 Single/multiple componentMetallic bone fixation appliances and accessories
Product Code:	KTT

Proposed Regulatory Class: Class II

Predicate Device:

Merete Locking Bone Plate System K090063 -
Merete MetaFix Small Fragment Bone Plate K050457 -
Merete BLP TM Small Fragment Locking Bone Plate System K063487 -
Merete 3.0 mm and 3.5 mm Locking Screws K081513 -
DARCO Locking Plate System K061808 -

Device Description:

Intended use:

The Merete Locking Bone Plate System II 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 II are similar to legally marketed predicate device listed above in that they share similar indications for use,

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are manufactured from similar materials and incorporate similar technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Merette Medical GmbH % Merete Medical, Inc. Mr. Emmanuel Anapliotis 49 Purchase Street Rye, New York 10580

DEC - 3 2013

Re: K102688

Trade/Device Name: Merete Locking Bone Plate System II Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 14, 2010 Received: September 17, 2010

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

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Page 2 - Mr. Emmanuel Anapliotis

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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

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/CDR/IOffices/ucm/ 1 5800.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 (2) 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 tollifi the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

For Rothman Mu

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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1. Indications for Use Statement

DEC - 3 2010

Indications for Use

510(k) Number (if known): K10268

Device Name: Merete Locking Bone Plate System II

Indications for Use:

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)

Oputu for mxn

(Dision Sign Off) Division of Surgical, Orthopcaic, and Restorative Devices

510(k) Number K102688

Regulation Number and Section

N/A