(91 days)
The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device.
The MECRON™ Cannulated Screw System consists of headed and headless bone screws and corresponding washers. The screws are offered in diameters from 2.0mm thru 7.0mm (in 0.5 mm increments) and overall lengths from 8 mm (for smaller diameters) thru 120 mm (for larger diameters). The cannulated screws have self-tapping and self-drilling features and are manufactured from medical grade titanium alloy (per DIN EN ISO 5832-3 and ASTM F136).
This document is a 510(k) premarket notification for a medical device (MECRON™ Cannulated Screw System). It does not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through mechanical testing for a physical orthopedic implant.
Therefore, I cannot extract the information required by your request about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable or detailed in this specific type of regulatory submission for this device.
The document states:
- "Clinical Data were not needed for these devices to show substantial equivalence."
- "Merete has conducted mechanical analysis and functional worst case tests to demonstrate that the MECRON™ Cannulated Screw System has the mechanical properties necessary to perform as well or better than the predicate device... These tests have been performed in accordance with ASTM F543-13."
This indicates that the "study" proving the device met its criteria was a series of mechanical and functional worst-case tests, not a clinical study involving human data, AI models, or expert human readers. The "acceptance criteria" were likely performance benchmarks derived from the predicate device and established standards like ASTM F543-13.
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October 23, 2017
Merete GmbH Paul Munch Head of Regulatory Affairs Alt-Lankwitz 102 Berlin, 12247 Germany
Re: K172213
Trade/Device Name: MECRON Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: September 27, 2017 Received: October 2, 2017
Dear Mr. Munch:
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 of medical 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
MECRON™ Cannulated Screw System
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
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510(k) Summary of Safety and Effectiveness Information as required by 21 CFR 807.92
| Date Prepared: | 27th July 2017 |
|---|---|
| Submitted by: | Merete GmbHAlt-Lankwitz 10212247 Berlin, Germany |
| Contact Person: | Merete GmbHPaul Münch (Head of Regulatory Affairs)Alt-Lankwitz 10212247 Berlin, GermanyPhone: +49-30 779980-181Fax: +49-30 779980-177 |
| Device Name: | MECRON™ Cannulated Screw System |
| Regulation/Classification Names: | 888.3040 Smooth or threaded metallic bone fixation fastener888.3030 Single/ multiple metallic bone fixation appliancesand accessories |
| Device Product Code: | HWC, HTN |
| Proposed Regulatory Class: | Class II |
Reference devices:
VILEX/DUVAL/ORTHEX Cannulated Bone Screw, Model F20-xx-00 K014154
Device Description:
The MECRON™ Cannulated Screw System consists of headed and headless bone screws and corresponding washers. The screws are offered in diameters from 2.0mm thru 7.0mm (in 0.5 mm increments) and overall lengths from 8 mm (for smaller diameters) thru 120 mm (for larger diameters). The cannulated screws have self-tapping and self-drilling features and are manufactured from medical grade titanium alloy (per DIN EN ISO 5832-3 and ASTM F136).
Indications for Use
The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.
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Image /page/4/Picture/1 description: The image shows the logo for Merete. The logo consists of two interlocking circles inside of a larger circle on the left. To the right of the circle is the name "merete" in a stylized font, with a registered trademark symbol above the "e" at the end of the name.
Comparison of technological characteristics with the predicate devices:
Merete has conducted mechanical analysis and functional worst case tests to demonstrate that the MECRON™ Cannulated Screw System has the mechanical properties necessary to perform as well or better than the predicate device and the reference device. These tests have been performed in accordance with ASTM F543-13. The MECRON Cannulated Screws have successfully passed all tests within the mechanical verification and have been proven to be mechanically as good as or better than the predicate device.
There are no differences in sterilization method or material in comparison to the predicate device. Sterilization has to be performed according to common valid standards as well as the material is specified according to common valid standards.
Clinical Data were not needed for these devices to show substantial equivalence.
Substantial Equivalence:
The MECRON™ Cannulated Screw System has passed all defined criteria, has performed as well or better than the predicate device and is therefore considered substantially equivalent to the cleared predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.