(77 days)
No
The 510(k) summary describes a mechanical bone plate system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a bone plate system used for fixation of fractures and reconstruction, which are surgical interventions rather than therapeutic treatments aimed at restoring or improving health by non-surgical means.
No
This device is a bone plate system used for fixation of fractures and bone reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Locking Bone Plate System" made of titanium alloy, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Merete Locking Bone Plate System is a surgical implant used to fix bones. It is made of titanium and is physically implanted into the body.
- Intended Use: The intended use is for the fixation of bone fractures, fusions, and reconstructions. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a medical device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
KTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers, and toes
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
2. 510(k) Summarv
| Submitted by: | Merete Medical GmbH
Alt Lankwitz 102,
12247 Berlin, Germany | DEC - 3 2010 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|--------------|
| FDA Registration Number: | 3002949614 | |
| Contact Person: | Emmanuel Anapliotis
Merete Medical, Inc.
49 Purchase Street
Rye, New York 10580
Phone: 914 967 1532 | |
| Device Name: | Merete Locking Bone Plate System II | |
| Device Classification: | 21 CFR 888.3030 Single/multiple component
Metallic 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:
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.
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,
1
are manufactured from similar materials and incorporate similar technological characteristics.
2
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
3
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:
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.
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