(103 days)
No
The 510(k) summary describes a mechanical bone plate system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described for fixation of fractures, joint fusion, and reconstruction, which are therapeutic interventions.
No
Explanation: The Merete Locking Bone Plate System is described as a medical device used for fixation of bones, and explicitly states its indications for use are for surgical procedures (fracture fixation, joint fusion, etc.). There is no mention of diagnostic capabilities, imaging, or analysis of patient data for diagnostic purposes.
No
The device description clearly states it consists of physical components like bone plates and screws made of titanium alloy, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Merete Locking Bone Plate System is a system of bone plates and screws made of titanium alloy. These are implanted devices used to fix bones.
- Intended Use: The intended use is for the fixation of fractures, revision procedures, joint fusion, and reconstruction of small bones. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant system, not a device used for testing biological samples.
N/A
Intended Use / 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.
Product codes
KTT
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) Submission - Merete Locking Bone Plate
2. 510(k) Summary
| Submitted by: | Merete Medical GmbH
Alt Lankwitz 102,
12247 Berlin, Germany | APR 22 2009 |
|----------------------------|-----------------------------------------------------------------------------------------------------------|-------------|
| FDA Registration Number: | 3002949614 | |
| Contact Person: | Jörg Mietzner
Merete Medical, Inc.
49 Purchase Street
Rye, New York 10580
Phone: 914 967 1532 | |
| Device Name: | Merete Locking Bone Plate System | |
| 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:
- 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.
1
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.
2
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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)