(91 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a bone screw system indicated for surgical procedures like bone reconstruction and fracture repair, which are supportive mechanical functions rather than active therapeutic interventions.
No
The device description and intended use indicate it is a surgical implant for bone reconstruction and fixation, not for diagnosing conditions.
No
The device description clearly states it consists of physical components (headed and headless bone screws and corresponding washers) made of medical grade titanium alloy. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation." These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as "headed and headless bone screws and corresponding washers" made from titanium alloy. This is a physical implant used in surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The MECRON™ Cannulated Screw System is a surgical implant, not an IVD.
N/A
Intended Use / 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 device.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3040 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.
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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
1
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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Image /page/3/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, and the word "merete" in a sans-serif font on the right. There is a registered trademark symbol to the upper right of the word "merete".
510(k) Summary of Safety and Effectiveness Information as required by 21 CFR 807.92
| Date Prepared: | 27th July 2017 |
|---|---|
| Submitted by: | Merete GmbH |
| Alt-Lankwitz 102 | |
| 12247 Berlin, Germany | |
| Contact Person: | Merete GmbH |
| Paul Münch (Head of Regulatory Affairs) | |
| Alt-Lankwitz 102 | |
| 12247 Berlin, Germany | |
| Phone: +49-30 779980-181 | |
| Fax: +49-30 779980-177 | |
| Device Name: | MECRON™ Cannulated Screw System |
| Regulation/ | |
| Classification Names: | 888.3040 Smooth or threaded metallic bone fixation fastener |
| 888.3030 Single/ multiple metallic bone fixation appliances | |
| and 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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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.