Guided Growth Plate System Plus

K172183 · Orthofix Srl · OBT · Jan 9, 2018 · Orthopedic

Device Facts

• Record ID: K172183
• Device Name: Guided Growth Plate System Plus
• Applicant: Orthofix Srl
• Product Code: OBT · Orthopedic
• Decision Date: Jan 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

Device Story

Guided Growth Plate System Plus is a metallic bone fixation system for pediatric orthopedic use. Device consists of contoured, low-profile 'eight-Plate' and 'quad-Plate' implants with cannulated or solid screws. Implanted on the external surface of bone across the physis; center hole allows temporary guide pin placement for surgical application. Screws are not locked to the plate, allowing them to swivel and diverge as bone grows. Device acts as a flexible hinge, redirecting bone growth to gradually straighten limbs. Used in clinical settings by surgeons to treat congenital or acquired deformities. Benefits include gradual, minimally invasive correction of angular deformities in growing patients without requiring osteotomy.

Clinical Evidence

No clinical data was needed to support safety and effectiveness. Evidence consists of bench testing and mechanical performance data. Mechanical testing followed ASTM F564-10. Biocompatibility and non-pyrogenicity were established using USP 38 <85>, USP 38 <161>, and ANSI/AAMI ST72:2011 standards.

Technological Characteristics

Metallic bone fixation plates (eight-Plate and quad-Plate) with cannulated/solid screws. Features contoured waist and low profile. Mechanical testing per ASTM F564-10. Biocompatibility testing per USP 38 and ANSI/AAMI ST72. Non-locked screw design allows divergence during growth.

Indications for Use

Indicated for growing children with angular growth deformities of long bones, including valgus, varus, flexion, extension, or plantar flexion deformities of the knee, ankle, elbow, or wrist. Contraindicated if physis (growth plates) are fused.

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 System Quad-Plate (K093442)

Submission Summary (Full Text)

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January 9, 2018

Orthofix Srl Gianluca Ricadona Sr. Quality & Regulatory Affairs Manager Via delle Nazioni. 9 97012 Bussolengo (VR) – Italy

Re: K172183

Trade/Device Name: Guided Growth Plate System Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OBT Dated: November 27, 2017 Received: November 29, 2017

Dear Gianluca Ricadona:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K172183

Device Name

Guided Growth Plate System Plus

Indications for Use (Describe)

The Guided Growth Plate System Plus is intended for redirecting the growth of long bones.

It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510(k) Summary

(as required by 21 CFR 807.92)

| Submitter | Orthofix Srl |
|-----------|-------------------------------|
| | Via delle Nazioni, 9 |
| | 37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |

| Contact Person | Gianluca Ricadona |
|----------------|------------------------------------------|
| | Sr. Quality & Regulatory Affairs Manager |
| Address | Via delle Nazioni, 9 |
| | 37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| email | [e-mail] |

07/14/2017 Date Prepared

| Trade Name | Guided Growth Plate System Plus |
|---------------------|--------------------------------------------------------|
| Common Name | Bone plate |
| Panel Code | 87 / Orthopaedic |
| Classification Name | plate, bone, growth control, pediatric, epiphysiodesis |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | OBT |

| Name of Predicate Device | 510(k) # | Manufacturer |
|---------------------------------|----------|--------------|
| Guided Growth System Quad-Plate | K093442 | Orthofix Srl |

| Description | The Guided Growth Plate System Plus is designed for the gradual<br>correction of pediatric congenital as well as acquired deformities in both<br>the upper and lower extremities, provided that the physis (growth plates)<br>are not fused.<br>It consists of different sizes of eight-Plate and quad-Plate plus with<br>different cannulated and solid screw options.<br>The plates feature a contoured waist and low profile for pediatric usage.<br>There is a center hole in the plates for a temporary guide pin to be<br>implanted, in order to aid application and removal of the plate.<br>The plates are attached to the external surface of the bone by screws,<br>which are not locked to the plate but rather they are allowed to swivel and<br>diverge in their position as bone growth occurs. The implant acts like a<br>flexible hinge, permitting growth at the growth plate to gradually straighten<br>the limb. |
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| Indications for | The Guided Growth Plate System Plus is intended for redirecting the |
| Indications for<br>Use | The Guided Growth Plate System Plus is intended for redirecting the<br>growth of long bones. It is indicated for gradually correcting angular<br>growth deformities in growing children.<br>Specific conditions/diseases for which the device will be indicated include:<br>valgus, varus or flexion, extension deformities of the knee (femur and/or<br>tibia); valgus, varus, or plantar<br>flexion deformities of the ankle; valgus or varus deformities of the elbow<br>(humerus), and radial or ulnar deviation, flexion or extension deformities<br>of the wrist (radius). |

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##

| Technological<br>Characteristics<br>and Substantial<br>Equivalence | Documentation was provided to demonstrate that the Subject device is<br>substantially equivalent to the predicate Guided Growth System Quad-<br>Plate (K093442) in the following fundamental aspects:<br>intended use, indications for use, site of application, patient population,<br>condition of use, technological characteristics, materials, mechanical<br>performances and implantable components.<br>Respect to the predicate, the Subject device provides design<br>improvements and additional dimensions for implantable components,<br>new sterile components and new related packaging configuration. |
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| Performance Data | The potential hazards have been evaluated and controlled through a Risk<br>Management Plan. |
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| | All testing met or exceeded the requirements, as established by the test<br>protocols and applicable standard. |
| | A review of the mechanical data indicates that the components of the<br>Subject device continues to be capable of withstanding expected loads<br>without failure. |
| | The Subject device was therefore found to be substantially equivalent to<br>the Predicate device and has the mechanical properties to perform its<br>indications safely. |
| | Clinical data was not needed to support the safety and effectiveness of<br>the Subject Device. |
| | The following standard has been followed to perform mechanical test on<br>the System configuration:<br>• ASTM F564 – 10 "Standard Specification and Test Methods for<br>Metallic Bone Staples". |
| Biocompatibility<br>data | In order to establish the Subject device non-pyrogenicity, some tests were<br>performed on an equivalent System devices, according to the following<br>international standard:<br>• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".<br>• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin and<br>pyrogen tests".<br>• ANSI / AAMI ST72: 2011 "Bacterial endotoxins - Test methodologies,<br>routine monitoring and alternative batch testing".<br>• FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing:<br>Question and Answers". |
| | Here below the tests reports and rationale references list:<br>• 8 Plate Plus_QE_RA01_r1, test rationale<br>• Orthofix Biological Evaluation report, dated 2015/05/11<br>• 16VA00534 validation report, dated 2015/05/11 |
| Conclusion | Based upon similarities in: intended use, indications for use, site of |

| Conclusion | Based upon similarities in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances, technology, materials and implantable components, Guided Growth Plate System Plus has been shown to be substantially equivalent to the legally marketed predicate device and to be safe and effective for its intended use. |
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