MC-Subtalar(TM) II

K160548 · Merete Medical GmbH · HWC · Apr 29, 2016 · Orthopedic

Device Facts

• Record ID: K160548
• Device Name: MC-Subtalar(TM) II
• Applicant: Merete Medical GmbH
• Product Code: HWC · Orthopedic
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion. Specific indications for use include: - Flexible flat feet in children and adolescence, - Progression medial talus protrusion, - Loss of longitudinal arch, - Pain along the tibialis posterior, - Age > 6 years, after conservative treatment did not result in a flat foot correction, - Age < 13 years, while the deformity may be corrected manually.

Device Story

MC-Subtalar™ II is a cannulated, self-tapping, partly threaded bone fixation screw; implanted into the calcaneus bone for subtalar extra-articular arthroereisis. Device blocks medial and plantar pronation of the talus while preserving subtalar joint motion. Used by surgeons in clinical settings to correct flexible flat feet in pediatric/adolescent patients. Hexagonal shaft end facilitates intraoperative adjustment. Available in multiple lengths (25-35 mm) and head diameters (6-10 mm) to accommodate anatomical variations. Device provides mechanical support to restore arch and alleviate pain associated with flat foot deformity.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including mechanical analysis and functional worst-case testing per ASTM F543-13, and biomechanical durability testing (10^6 load cycles).

Technological Characteristics

Materials: X2CrNiMo 18-15-3 stainless steel or Ti6Al4V titanium alloy. Design: Cannulated, self-tapping, partly threaded screw with hexagonal shaft end. Sizes: 25/30/35 mm lengths; 6/8/10 mm head diameters. Testing: ASTM F543-13 compliant mechanical testing.

Indications for Use

Indicated for children (6 to <12 years) and adolescents (12 to <13 years) with flexible flat feet, progressive medial talus protrusion, loss of longitudinal arch, and pain along the tibialis posterior, where conservative treatment failed and deformity is manually correctable.

Regulatory Classification

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.

Predicate Devices

• Pellegrin Calcaneus Stop Screw (K133035)

Reference Devices

• Disco Subtalar Implant (K111834)
• Foot surgery screws (K152187)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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 < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion.

Specific indications for use include:

- · Flexible flat feet in children and adolescence,
- · Progression medial talus protrusion,
- · Loss of longitudinal arch,
- · Pain along the tibialis posterior,
- · Age > 6 years, after conservative treatment did not result in a flat foot correction,
- · Age < 13 years, while the deformity may be corrected manually.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 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 word "merete" in a dark blue, sans-serif font, with a registered trademark symbol in the upper right corner.

# 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<br>Alt-Lankwitz 102<br>12247 Berlin, Germany |
| Contact Person: | Matthias Möllmann<br>Merete Technologies, Inc. (MTI)<br>One Lincoln Centre<br>18W140 Butterfiled Road, 15th Floor<br>Oakbrook Terrace, IL 60181<br>Phone: [phone] |
| 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.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Merete logo. The logo consists of two interlocking circles inside of a larger circle on the left, followed by the word "merete" in a serif font. There is a registered trademark symbol to the right of the word.

### Indications for use

The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion.

Specific indications for use include:

- Flexible flat feet in children and adolescence,
- Progression medial talus protrusion,
- . Loss of longitudinal arch,
- Pain along the tibialis posterior,
- . Age > 6 years, after conservative treatment did not result in a flat foot correction,
- Age < 13 years, while the deformity may be corrected manually.

### Comparison of technological characteristics with the predicate devices:

In order to demonstrate that the MC-Subtalar™ II has the mechanical properties necessary to perform as well or better than the predicate devices, Merete has conducted mechanical analysis and functional wort case tests. This tests have been performed in accordance with ASTM F543-13. Additionally a biomechanical tests has been performed to evaluate the durability of the MC-Subtalar™ II screws with 106 load cycles in a worst-case scenario. The MC-Subtalar™ II screws have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices. Differences in sterilization method and material have been addressed by pointing out to reference devices using the same methods/ materials.

Clinical Data were not needed for these devices to show substantial equivalence.

### Substantial Equivalence:

The MC-Subtalar™ II have passed all defined criteria, have performed as well or better than the predicate device and are therefore considered substantially equivalent to the cleared predicate device.