GAP ENDO-EXO MEDULLARY SYSTEM

{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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single, flowing shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 23, 2016 Pega Medical Inc. Ariel R. Dujovne President 1111 Autoroute Chomedey Laval, Quebec H7W 5J8 Canada Re: K160545 Trade/Device Name: Gap Endo-Exo Medullary System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 18, 2016 Received: April 19, 2016 Dear Ariel R. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Expiration Date: January 31, 2017 510(k) Number (if known GAP Endo/Exo Medullary System Device Name Indications for Use (Describe) indicated for correction of the following conditions: si il .I və səsr (11925) və birin) sinfinin ədədi ilə bəsn si mərkiyyə yaşlıqların və ya ədə ədil əsasən və of o notisxil pur substility is internet is se temporary im sure aligniment, stabilization and filization and filization and filization and filization and filization and filizatio - Diaphysess fracture of the femur, tibis and humerus - Fractures of the femoral neck - Subtrochanteric, intertrochanteric and combination fractures - Correction of deformities (OI, Coxa vara, Coxa vara, Coxa valga - Nounnious and malunions Type of Use (Select one or both, as applicable) 2 Presscription Use (Fart 21 CFR 801 Suppart D Over-The-Counter Use (2) CFR 801 Subpart C # DIGGEN FI FE FERRETARA PARA PARA PERFECT WASHINGTON is of Sell SEND YOUR SECTION HAPPENINGS TO: IEEE Region 5 Newsletter 4451 Brookside Blvd. #200 Kansas City, MO 64112 *Deadline for next issue: December 1993* O NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* PLEASE READ INSTRUCTIONS BELOW. **DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS.** TED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. SEND YOUR COMPLETED FORM TO THE EPPA STAFF EMAIL ADDRESS BELOW.* COMPLETE THIS SECTION AND INCLUDE WITH YOUR APPLICATION. FAILURE TO DO SO WILL RESULT IN YOUR APPLICATION NOT BEING PROCESSED. *NOTE: PLEASE ENSURE THAT YOU HAVE COMPLETED ALL SECTIONS OF THE APPLICATION FORM PRIOR TO SUBMISSION. FAILURE TO DO SO WILL RESULT IN YOUR APPLICATION NOT BEING PROCESSED. EMAIL ADDRESS FOR EPRA STAFF: INSTRUCTIONS: PLEASE DO NOT SEND YOUR COMPLETED FORM TO THE EPPA STAFF EMAIL ADDRESS BELOW. ** *PLEASE PRINT. MAKE SURE ALL INFORMATION IS COMPLETE AND SEND YOUR COMPLETED FORM TO THE EPRA STAFF EMAIL ADDRESS BELOW.* NOT SEND YOUR COMPLETED FORM TO THE EMAIL ADDRESS BELOW. *THIS IS A VALID EMAIL ADDRESS ONLY FOR STAFF ADDRESSING QUESTIONS. SEND YOUR COMPLETED FORM TO THE EPPA STAFF EMAIL ADDRESS BELOW. * PLEASE BE SURE TO SEND YOUR COMPLETED FORM TO THE EPRA STAFF EMAIL ADDRESS BELOW.* IN ORDER TO RECEIVE THE HASP ALLOTMENT, PLEASE PROVIDE THE FOLLOWING INFORMATION REQUESTED BELOW.** INSTRUCTIONS FOR COMPLETING THIS FORM: PLEASE READ THESE INSTRUCTIONS BEFORE YOU COMPLETE THIS FORM. *NOTE: PLEASE EMAIL ADDRESS BELOW FOR COMPLETED FORMS. PLEASE RETURN COMPLETED FORM TO THE EPRA STAFF EMAIL ADDRESS BELOW.* CONSIDER YOUR COMPLETED FORM TO THE EPPA STAFF EMAIL ADDRESS BELOW.* OT SEND YOUR COMPLETED FORM TO THE EPRA STAFF EMAIL ADDRESS BELOW.* ime for this *OT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* time for this is to 70 OT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* cime for this collection of information is estimated to average 79 hours per response. including time for this collection of information is estimated to average 79 hours per response, including instructions time for this collection of information is estimated to average 79 hours per response, including NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." en time for this collection of information is estimated to average 79 hours per response, including t in the suited to average 7 B hours personse, including the time for this collection of information is estimated to average 79 hours per response, including e for this collection of information is estimated to average 79 hours per response, includin cime for this collection of information is estimated to average 79 hours per response, includin time for this collection of information is estimated to average 79 hours per response, includin e for this collection of nation is estimated to average 15 hours per response, inclu ew instructions, search existing data sources, gather and maintain the data needed and co the Paperwork Reduction Act (PRA) Staff Department of Health and Human Service Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff Office of Chief Information Officer Food and Drug Administration Department of Health and Human Services əsindən bir bəhri və qalında ilk birinci bir nəzərində bir sinfi olan və bir mənin ən bir və bir və bir və bir və bir və bir və bir və bir və bir və bir : how side sing prisuber of suoitseppus pribuloni , noitemoni sidh to | નવાન | | |---------------------------------------------------------------------------------|---------------------| | and the first the first of the first of the first of the first of the first for | | | | | | as and to anitos from and and and the sentif | 2<br>-1 16, 11 1000 | | | 1 | | | | | | - 48 80 | | | 12 | | | | | | 1 | |----------------|--------------| | ە ﻳﯩﻠﻠﯩ | ﺗ | | | e | | | | | | 5<br>14 | | S | mr.<br>"IDen | | | | | 11/01/103 | | | | | | | | | | | | | ime | | | unt | | | | | | | | | | | | 100<br>5 | | | - | | panitar misali | | | | 44 | | | | | | SI | | | | | | | | | collection | | 401000 | | | | | | | | | | | | | | | | | | | 10<br>30 | | | | | | 3<br>= | | | | | | | | onitains | annot | | | | | | TOTTITA | | an | | | | | | 1 | | |-----------|-------| | 1 | | | | | | | | | | | | 1 | | | 1 | | | | | | 188/09/91 | | | | | | | | | | | | | | | | | | | | | 1 | 0 | | | | | ﺍﻟﻤﺘﺤﺪﺓ | | | | | | | | | | | | | | | | | | | | | | | | | | | | - 1 - | | | | | 1 | | | | | | | | | | , | | | | | 1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1 | | | | | | | | | | | | | | | | | | | P | | | | | 1 | | | | | | | 1 | | | | | | | | | 1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | FORM FDA 3881 (814 Page 1 of 1 information unless it displays a currently valid OMB number Other Information Officer Paperwork Reduction Act (PRA) Staff oeda.hhs.gov PRAStaff@fda.hhs.goov suggestions for reducing this burden, to partment of Health and Human Service od and Drug Administration ice of Chief Information Officer D YOUR COMPLETED FORM TO THE PRA STAFF E his collection of information is estimated to average 79 ctions, search existing data sources, gather and mainta SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS FOR YOUR REGION. e (Part 21 CFR 801 Subран D) Over-The-Counter Os s applicable) (Part 21 CFR 801 Subpart D) 801 Subpart D) ☐ Over-T - Over-The-Counter Use (21C t D) ☐ Over-The-Cou Over-The-Counter Use (21) ts (child and adolescent) (ages 2 υπη Αρριοved. OMB NO. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## ndications for Use K160545 tions for Use (Describe) LAP Endo-Exo Medullary Sys (another) Model/Flow Surface is indicated as downward to account for diminished reflectivity. Approved: OMB No.0910-012 Diration Date: January 31, 2017 e PRA Statement below. || 45 Number (if known) Form Approved: OMB No. 09 Expiration Date: January 31, See PRA Statement below Form Approved: OM8 Mo. 0810-0120 See PRA Statement below. Use (21 CFR 801 Subpart C) equired to respond to a collection of to united on conduct or sponsor, and e product or segment to, a collocity on SC Publishing Services (301) 443-6740 Fri ly valid OMB number. {3}------------------------------------------------ ### Wednesday, November 22nd, 2016 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Applicant : Pega Medical Inc. 1111 Highway Chomedey Laval, Quebec, Canada, H7W 5J8 Phone :1-877-739-5175 Fax :1-888-258-0760 Contact Person : Ariel R. Dujovne Proprietary Name : GAP Endo-Exo Medullary System Common Name : Intramedullarv Nail Device Classification : Class II Classification Name : Rod, Fixation, Intramedullary And Accessories 21 CFR 888-3020 Device Product Code : нгв Establishment Registration Number : 9048931 ### Intended Use: The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions: - Diaphyseal fracture of the femur, tibia and humerus ● - . Fractures of the femoral neck - Subtrochanteric, intertrochanteric and combination fractures ● - . Correction of deformities (OI, Coxa vara, Coxa valga) - . Nonunions and malunions ### Description: The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via lag and/or mechanical screws creating a combined Endomedullary/ Exomedullary osteosythesis device. The nail is available is diameters ranging from 4.8 to 12.0mm in 0.8mm increments. Lengths available range from 160 to 320mm. 2.5, 3 and 4mm cortical screws are used to secure the nail to the bone. ### Basis for substantial equivalent: The GAP Endo-Exo Medullary System is claimed to be substantially equivalent in design and function to the following predicate devices: - 1. The GAP Endo-Exo Medullary System, Pega Medical Inc. [K111232] - 2. The Fassier-Duval Telescopic IM System (Stainless steel or Ti pediatric Nail), Pega Medical Inc. [K041393/K020885] {4}------------------------------------------------ The intended use remains unchanged from the original GAP Endo-Exo Medullary System (K111232). Design changes have been validated via in-vitro biomechanical testing, when deemed necessary. The dimensional modification to the device maintains the effectiveness and increases the safety of the device. ### Summary of Technologies: The technological characteristics of the GAP Endo-Exo Medullary System are the same or similar to the ones of the predicate devices. The subject device uses the exact same lag and mechanical screws to fix onto the various plates at the level of the proximal femur. However, for distal locking of the subject device was redesigned for locking with Ø2.5mm unicortical pins instead of Ø3.0mm bicortical screws in the Ø4.8mm GAP Nail, which increases the mechanical resistance and fatigue life of the Ø4.8mm GAP Nail at the level of the distal pinning because of the reduction in the size of the locking holes when compared to the predicate device. ### Non-clinical Performance Data: The proposed modification on the design of the distal holes of the 4.8 mm GAP Nail was tested through bench testing in static and fatigue loading with an offset axial compression test set-up. The results indicate that the new design increases mechanical resistance and fatigue life compared to the predicate Ø4.8mm GAP Nail design [K111232]. No Animal or Clinical testing was performed. ### Clinical Performance Data: No clinical testing is provided as a basis for substantial equivalence. ### Conclusion: Based on the similarities of intended use, design, materials, manufacturing methods and packaging, the GAP Endo-Exo Medullary System has been established substantially equivalent to the previously cleared predicate devices. The literature supports the use of this product as safe and effective for its intended use; the anticipated benefits of such system outweigh any possible residual risks.