PediatrOS RigidTack/FlexTack

K151762 · Merete Medical GmbH · JDR · Dec 28, 2015 · Orthopedic

Device Facts

• Record ID: K151762
• Device Name: PediatrOS RigidTack/FlexTack
• Applicant: Merete Medical GmbH
• Product Code: JDR · Orthopedic
• Decision Date: Dec 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PediatrOS™ RigidTack™/ FlexTack™ bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOS™ RigidTack™ / FlexTack™ is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents. Specific pediatric conditions/diseases for which the devices will be indicated include: - Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia) ● - Valqus or varus deformities of the elbow (humerus) ● - Leg length discrepancies

Device Story

PediatrOS™ RigidTack™/FlexTack™ are titanium alloy (TiAl6V4 ELI) bone staples for pediatric orthopedic growth modulation. RigidTack™ provides stiff mechanical fixation for epiphysiodesis; FlexTack™ features a flexible middle section allowing in vivo bending via bone growth forces for hemiepiphysiodesis. Both devices feature trapezoidal geometry, jagged legs for bone fixation, and cannulated legs for K-wire guided placement. Female threads in legs facilitate removal. Used by surgeons to correct angular deformities or leg length discrepancies in growing children. Benefit: minimally invasive growth modulation to correct skeletal alignment without major corrective osteotomy.

Clinical Evidence

Bench testing only. Mechanical strength, stiffness, mechanical behavior, and bone fixation tests were performed. Testing confirmed mechanical properties are as high or higher than predicate devices. No clinical data presented.

Technological Characteristics

Material: Titanium alloy TiAl6V4 ELI. Design: Trapezoidal bone staples with cannulated legs and jagged surfaces. FlexTack™ includes a flexible bending zone. Standards: ASTM-F564-10(2015). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for pediatric patients (children/adolescents) with angular deformities (valgus, varus, flexion, extension of knee; valgus, varus of elbow) or leg length discrepancies requiring growth redirection or longitudinal growth inhibition of the physis.

Regulatory Classification

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.

Predicate Devices

• Guided Growth Plate (K031493)
• Blount Zimmalloy staple, Zimmer Inc.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 28, 2015

Merete Medical GmbH % Mr. Matthias Möllmann Senior Vice President Merete Medical, Incorporated 4 Crotty Lane, Suite 118 New York International Plaza New Windsor, New York 12553

Re: K151762

Trade/Device Name: PediatrOSTM RigidTack™/FlexTack™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, OBT Dated: December 8, 2015 Received: December 11, 2015

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 (reporting of medical device

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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.

Ronald P. Jean - S for

Mark N. Melkerson Director Division of Orthopedic 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): K151762

Device Name: PediatrOS™ RigidTack™ / FlexTackTM

Indications for Use:

The PediatrOS™ RigidTack™/ FlexTack™ bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOS™ RigidTack™ / FlexTack™ is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents.

Specific pediatric conditions/diseases for which the devices will be indicated include:

- Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia) ●
- Valqus or varus deformities of the elbow (humerus) ●
- Leg length discrepancies ●

Prescription Use (Part 21 CFR 801 Subpart D)

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)

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Image /page/3/Picture/0 description: The image shows the logo for Merete. The logo consists of two interlocking circles on the left, followed by the word "merete" in a sans-serif font. A registered trademark symbol is located to the upper right of the word "merete". The logo is in a dark blue color.

# 510(k) Summary of Safety and Effectiveness Information

#### as required by 21 CFR 807.92

| Date Prepared: | 04th December 2015 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Merete Medical GmbH<br>Alt-Lankwitz 102<br>12247 Berlin, Germany |
| Contact Person: | Matthias Möllmann<br>Senior Vice President<br>Merete Medical, Inc.<br>4 Crotty Lane - Suite 118<br>New York International Plaza<br>New Windsor, NY 12553<br>Phone: [phone]<br>E-Mail: [e-mail] |
| Device Name: | PediatrOS™ RigidTack™/FlexTack™ |
| Common Name: | Bone Staples |
| Classification Names: | Single/multiple component metallic bone fixation<br>appliances and accessories 21 CFR 888-3030 |
| Device Product Code: | JDR |
| Subsequent Product Code: | OBT |
| Proposed Regulatory Class: | Class II |

#### Legally marketed Devices to which substantial Equivalence is claimed:

K031493 Guided Growth Plate, UNIVERSITY OF UTAH/SCHOOL OF MEDICINE Blount Zimmalloy staple, Zimmer Inc. Warsaw, Indiana -

#### Device Description:

#### PediatrOS™ RigidTack™

The PediatrOS™ RigidTack™ bone staples are used to correct leg length discrepancies through (dual) epiphysiodesis of long bones. The PediatrOS™ RigidTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELI and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surfaces of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires. In order to achieve a stiff mechanical behavior, the staples are equipped with a support strut. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.

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Image /page/4/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, and the word "merete" in blue font on the right. There is a registered trademark symbol to the right of the word.

### PediatrOS™ FlexTack™

The PediatrOS™ FlexTack™ bone staples are used to correct axial deformities through hemiepiphysiodesis of long bones. The PediatrOS™ FlexTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELl and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surface of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires as well as a flexible middle part which can be bent in vivo by the strength of bone growth permitting successive growth delay. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.

### Indications for Use

The PediatrOS™ RigidTack™ / FlexTack™ bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOS™ / FlexTack™ is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents.

Specific pediatric conditions/diseases for which the devices will be indicated include:

- Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia)
- . Valgus or varus deformities of the elbow (humerus)
- Leg length discrepancies

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

In order to demonstrate that the PediatrOS™ RigidTack™ / FlexTack™ bone staples have the mechanical properties necessary to perform as well as or better than the predicate devices, Merete has conducted mechanical analysis and functional worst-case tests were stipulated by the optimatized design of the staple legs compared to the Blount Zimmalloy staple and the differences in the mechanism of growth following compared to the guided growth plate. The PediatrOS™ FlexTack™ has a flexible bending zone in contrast to a rigid plate with screw holes that allow screw displacement in distal-proximal direction in the guided growth plate. Therefore the following tests have been performed:

- Mechanical strength
- Stiffness
- Mechanical behavior
- Fixation into the bone

Those tests have demonstrated, that the mechanical strength is as high or higher than the strength of the predicate device. The stiffness is comparable to both predicate devices, too. The mechanical behavior comparison illustrated that the flexible bending zone in FlexTack™ deforms under small loads as intended and allows larger opening angles than physiological possible. A secure fixation into the bone was proven. If applicable the tests were performed according to valid standards as ASTM-F564-10(2015).

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Image /page/5/Picture/0 description: The image shows the logo for Merete. The logo consists of a circular graphic on the left and the word "merete" in a dark blue sans-serif font on the right. A registered trademark symbol is located to the right of the word.

All products have successfully passed the tests. The PediatrOS™ RigidTack™ / FlexTack™ bone staples have hereby been proven to be mechanically as good as or better than the compared predicate devices.

# Substantial Equivalence:

The PediatrOS™ RigidTack™ / FlexTack™ bone staples have passed all defined criteria, have performed as well or better than the predicate devices and are therefore considered substantially equivalent to the cleared predicate devices.