The GIRO Growth Modulation System

{0}------------------------------------------------ October 24, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety. Pega Medical, Inc. Ariel Dujovne Official Correspondent 1111 Autoroute Chomedev Laval, Quebec H7W 5J8 Canada Re: K220190 Trade/Device Name: The GIRO Growth Modulation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OBT, HWC Dated: September 15, 2022 Received: September 16, 2022 Dear Ariel Dujovne: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220190 Device Name The GIRO Growth Modulation System #### Indications for Use (Describe) The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions: - [ Femur and tibia: varus, valgus, flexion, or extension deformities of the knee. - □ Humerus: valgus or varus deformities of the elbow. - □ Radius and ulna: flexion or extension deformities of the wrist. - □ Ankle: varus, valgus or plantar flexion deformities of the ankle. - □ Limb length discrepancy of the femur and tibia. Type of Use (Select one or both, as applicable) X 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 Drug 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}------------------------------------------------ ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Applicant: | Pega Medical Inc.<br>1111 Highway Chomedey<br>Laval, Quebec, Canada, H7W 5J8<br>Phone: 1-877-739-5175 | |------------------------------------|-------------------------------------------------------------------------------------------------------| | Contact Person: | Ariel R. Dujovne | | Proprietary Name: | The GIRO™ Growth Modulation System | | Common Name: | GIRO™ System | | Regulation Number: | 21 CFR 888.3030 | | | Single/multiple component metallic bone fixation<br>appliances and accessories. | | Device Classification: | Class II | | Device Classification Panel: | Orthopedic | | Device Classification Name: | Plate, Bone, Growth Control, Pediatric, Epiphysiodesi | | Device Product Code: | OBT, HWC | | Establishment Registration Number: | 9048931 | #### Intended Use: The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions: - 트 Femur and tibia: varus, valgus, flexion, or extension deformities of the knee. - " Humerus: valgus or varus deformities of the elbow. - . Radius and ulna: flexion or extension deformities of the wrist. - . Ankle: varus, valgus or plantar flexion deformities of the ankle. - . Limb length discrepancy of the femur and tibia. #### Description: The GIRO™ Growth Modulation System is a tether device used for quided growth and deformity correction. It includes two couplings linked via a flexible cable and anchored to the bone via screws and bi-cortical posts. By tethering the growth plate, angular deformities can be corrected. The implants are manufactured in medical grade 316L stainless steel (ASTM F138) and offered in two sizes: 4.5 and 6.0. #### Basis for substantial equivalence: The GIRO™ Growth Modulation System is claimed to be substantially equivalent in design, indicated use and function to the following devices: | | Labeling Name | Marketed by | MDL number | 510(k) number | |--------------------------------|----------------------------------------------------------------------|---------------------------|------------|--------------------------------------------------------------------------------| | Primary Predicate<br>device | Hinge Pediatric Plating<br>System | Pega Medical Inc. | 80588 | K090440 | | Additional<br>Predicate device | PediatrOS<br>RigidTack/Flextack | Merete Medical<br>GMBH | N/A | K151762 | | Reference device | OrthoPediatrics<br>PediPlates System | OrthoPediatrics,<br>Corp. | 97840 | K090666 | | Reference device | Guided Growth System<br>Eight-Plate, Quad-Plate<br>(Stainless Steel) | Orthofix Inc. | 70083 | K110805 | | Reference device | Fixation Staples,<br>BLOUNT Staples<br>Epiphyseal | Stryker Corp. | 11011 | K834513 | | Reference device | Zimaloy Epiphyseal<br>Staple | Zimmer Inc. | 10944 | Grandfathered;<br>literature shows<br>product used since<br>1949(Blount, 1949) | Blount WP, Clarke GR. 1949. Control of bone growth by epiphyseal stapling: a preliminary report. J Bone Joint Surg 31A:464-478. {4}------------------------------------------------ ## Summary of Technologies: The technological characteristics of the GIRO™ System are similar to the ones of the predicate and reference devices for the described intended uses, with a flexible tether that is designed to better conform to the surface of the bone. For temporary epiphysiodesis, unlike predicate and reference devices, the use of bi-cortical telescoping posts is suggested over the use of screws or staples due to its better surface contact above and below the growth plate. The mating of the screws and posts into the spherical seating of the couplings allows this low-profile implant to minimize interference with the surrounding tissues. ## Non-clinical Performance Data: Verification calculations were completed to evaluate resistance of the GIRO™ System in comparison to the predicate and reference systems, such as the Hinge Plate, Eight-Plate, RigidTack/FlexTack systems, and the Zimaloy Epiphyseal Staple. The mechanical properties of all the GIRO™ System posts, screws, cable, and couplings components were analysed in comparison to the predicate and reference systems as well as physiological loads documented in literature. Furthermore, bench testing of the GIRO™ System confirmed the validity of the analysis. Results of the bench testing of the GIRO™ System and primary predicate demonstrate equivalent performance. As per the findings of the bench testing and the clinical performance of the primary predicate, the data supports the use of GIRO™ System as safe and effective for its intended use; the anticipated benefits of such a system clearly outweigh the possible residual risks. A list of the tests carried out for this application can be found below: - . Static vertical tension of the GIRO - Static tension of the GIRO assembly in foam block - Insertion torque of the Screws - . Insertion torque of the Posts - . Removal torque of the Screws - Removal torque of the Posts - Axial pullout of the Screws - . Axial pullout of the Posts - Breaking torque of the Screws - Breaking torque of the Posts - Static 3-point bending of the Screws - . Static 4-point bending of the Post assembly - . Surgical technique validation of the prototypes ## Clinical Performance Data: No clinical testing is provided as a basis for substantial equivalence. ## Conclusion: Based on the similarities in the intended use, design, materials, manufacturing methods, and packaging, the GIRO™ System has been established as substantially equivalent to the previously cleared predicate and reference devices. Furthermore, mechanical evaluation results demonstrate that the proposed system is substantially equivalent or superior to the predicate and reference devices.