(60 days)
No
The device description and performance studies focus solely on the mechanical properties and surgical application of a bone screw, with no mention of AI or ML technology.
Yes
The device is intended for the correction of flexible flat feet. It explicitly states its purpose is to "block medial and plantar pronation of the talus" to treat a medical condition (flexible flat feet, including pain and loss of arch), which aligns with the definition of a therapeutic device.
No
Explanation: The device is a surgical screw system intended for the correction of flexible flat feet. It is an implantable device used for treatment, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical screw made of stainless steel or titanium alloy, intended for surgical implantation. It does not mention any software components.
Based on the provided information, 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 and Intended Use: The MC-Subtalar™ II screw system is a surgical implant designed to be placed directly into the calcaneus bone of the foot. Its purpose is to physically correct a structural issue (flexible flat feet) by blocking pronation of the talus.
- Lack of Biological Sample Testing: There is no mention of this device being used to test biological samples or provide diagnostic information based on such testing.
The device is a surgical implant used for a mechanical correction of a musculoskeletal condition.
N/A
Intended Use / Indications for Use
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to 6 years, after conservative treatment did not result in a flat foot correction,
-Age
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merete Medical GmbH % Mr. Matthias Möllmann Senior Vice President Merete Technologies Incorporated One Lincoln Center 18W140 Butterfield Road Oakbrook Terrace, Illinois 60181
April 29, 2016
Re: K160548
Trade/Device Name: MC-Subtalar™ II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 23, 2016 Received: February 29, 2016
Dear Mr. Möllmann:
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
1
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.
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 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 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 yours,
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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Indications for Use
510(k) Number (if known) K160548
Device Name MC-Subtalar™ II
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to 6 years, after conservative treatment did not result in a flat foot correction,
- · Age 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: | 25th April 2016 |
|---|---|
| Submitted by: | Merete Medical GmbH |
| Alt-Lankwitz 102 | |
| 12247 Berlin, Germany | |
| Contact Person: | Matthias Möllmann |
| Merete Technologies, Inc. (MTI) | |
| One Lincoln Centre | |
| 18W140 Butterfiled Road, 15th Floor | |
| Oakbrook Terrace, IL 60181 | |
| Phone: 630-613-7181 | |
| Device Name: | MC-SubtalarTM II |
| Common Name: | Subtalar Arthroereisis Implant |
| Classification Names: | Smooth or threaded metallic bone fixation fastener - 888.3040 |
| Device Product Code: | HWC |
| Proposed Regulatory Class: | Class II |
Legally marketed Devices to which substantial Equivalence is claimed:
K133035 Pellegrin Calcaneus Stop Screw, Normed Medizin-Technik GmbH
Reference devices:
| K111834 | Disco Subtalar Implant, Trilliant Surgical LTD |
|---|---|
| K152187 | Foot surgery screws, Merete Medical GmbH |
Device Description:
The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.
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Indications for use
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to 6 years, after conservative treatment did not result in a flat foot correction,
- Age