Airlock Centrolock Osteosynthesis Implant System

{0}------------------------------------------------ December 14, 2019 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Novastep Gilles Audic QA/RA Director Espace Performance III- Batiment P Saint-Gregoire, 35769 FR Re: K192356 Trade/Device Name: Airlock Centrolock Osteosynthesis Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 19, 2019 Received: August 29, 2019 Dear Gilles Audic: 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). 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Sincerely, Shumaya Ali, MPH 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 Statement | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|----------------------------------------------------| | Food and Drug Administration | | | | Form Approved: OMB No. 0910-0120 | | | Expiration Date: 06/30/2020 | | | See PRA Statement below. | | 510(k) Number (if known) | K192356 | | Device Name | Airlock® Centrolock® osteosynthesis implant system | **Indications for Use (Describe)** Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes. Examples include: - Mono or Bi-Cortical osteotomies in the foot or hand - Distal or Proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - Calcaneus/cuboid arthrodesis - Talar/navicular arthrodesis The system may be used in adult patients. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <span> <label><input checked="checked" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> | <span> <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> | 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}------------------------------------------------ # tep® #### "510(k) Summary" as required by section 807.92(c) | Submitter | NOVASTEP | |------------------|-----------------------------------------| | | Espace performance 3 | | | Bâtiment P | | | 35769 SAINT GREGOIRE CEDEX | | | France | | | Phone: +33 (0)2 99 33 86 50 | | | Fax: +33 (0)9 70 29 18 95 | | Contact person | Mister Gilles AUDIC | | | QA / RA Director | | | Cell phone:+33 (0)6 30 93 96 08 | | | e-mail: gilles.audic@novastep-ortho.com | | Preparation date | December 13 2019 | | Trade name | Airlock® Centrolock® osteosynthesis implant system | |---------------------|---------------------------------------------------------------------------------------------------------------------| | Common Name | Plate, Fixation, Bone | | Classification Name | Single / Multiple component metallic bone fixation appliances and<br>accessories (21CFR 888.3030, product code HRS) | | Regulatory class | II | | Legally marketed<br>predicate devices | Primary predicate device<br>510(k) number: K120157<br>Device name: Mini MaxLock Extreme® Plating System<br>Original applicant: OrthoHelix Surgical Designs, Inc. | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Reference device | | | 510(k) number: K143523 | | | Device name: Airlock® Osteosynthesis Plate System | | | Original applicant: NOVASTEP. | | | Other predicate | | | 510(k) number: K162353 | | | Device name: MICA™ Screw System | | | Original applicant: Wright Medical Technology, Inc.. | | Description | Airlock® Centrolock® osteosynthesis implant systems are single-use bone<br>fixation devices intended to be permanently implanted. implant systems<br>are designed with different shapes and are made of Titanium (Alloy Ti-<br>6Al-4V ELI).<br>The system uses either 2mm cortical screws or 2,5mm locking screws.<br>The drill holes are aligned to make sure there is no risk of conflict between<br>the screws.<br>The implant vary essentially through different curvatures and shapes. | | Intended use | Airlock® Centrolock® osteosynthesis implant systems are single-use<br>devices intended for fixation and stabilization of fresh fractures,<br>revision procedures, joint fusion and reconstruction of small bones of<br>the hands, feet, ankle, fingers and toes.<br>Examples include: | | | • Mono or Bi-Cortical osteotomies in the foot or hand | | | • Distal or Proximal metatarsal or metacarpal osteotomies | | | • Fixation of osteotomies for Hallux Valgus treatment (such as Scarf,<br>Chevron, etc.) | | | • Calcaneus/cuboid arthrodesis | | | • Talar/navicular arthrodesis | | | The system may be used in adult patients. | | Comparison of the<br>technological | The new devices Airlock® Centrolock® osteosynthesis implant system<br>implants have similar technological characteristics in terms of design<br>and mechanical characteristics [Static and dynamic bending resistance | | characteristics with the<br>predicate device | (ASTM-F382-17) and thus are believed to be substantially equivalent to<br>the predicate Novastep Airlock® osteosynthesis Plate System.<br>The new devices Airlock® Centrolock® osteosynthesis implant system<br>screws have similar technological characteristics in terms of design and<br>mechanical characteristics (pull-out strength, torsional resistance<br>(ASTMF543-17 sections A1 A3) and thus are believed to be<br>substantially equivalent to the predicate Novastep Airlock®<br>osteosynthesis Plate System. | | Performance data | The biocompatibility evaluation for new devices Airlock® Centrolock®<br>osteosynthesis implant systems was conducted in accordance with Blue<br>Book Memorandum #G95-1 "Use of International Standard ISO-10993,<br>'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'"<br>and International Standard ISO 10993-1 "Biological Evaluation of Medical<br>Devices - Part 1: Evaluation and Testing Within a Risk Management<br>Process" as recognized by FDA. | | | The new devices Airlock® Centrolock® osteosynthesis implant system<br>implants have similar technological characteristics in terms of material<br>(ISO 5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic<br>Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)<br>and thus are believed to be substantially equivalent to the primary<br>predicate legally marketed device OrthoHelix Surgical Designs Mini<br>MaxLock Extreme® Plating System (K120157), and the reference device<br>marketed Novastep Airlock® osteosynthesis Plate System (K143523). | | | The new devices Airlock® Centrolock® osteosynthesis implant system<br>screws have similar technological characteristics in terms of material (ISO<br>5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic<br>Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)<br>and thus are believed to be substantially equivalent to the primary<br>predicate legally marketed device OrthoHelix Surgical Designs Mini<br>MaxLock Extreme® Plating System (K120157), and the reference device<br>marketed Novastep Airlock® osteosynthesis Plate System (K143523). | | Indication for use | Airlock® Centrolock® osteosynthesis implant systems are single-use<br>devices intended for fixation and stabilization of fresh fractures,<br>revision procedures, joint fusion and reconstruction of small bones of<br>the hands, feet, ankle, fingers and toes.<br>Examples include:<br>• Mono or Bi-Cortical osteotomies in the foot or hand<br>• Distal or Proximal metatarsal or metacarpal osteotomies<br>• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf,<br>Chevron, etc.) | | | • Calcaneus/cuboid arthrodesis<br>• Talar/navicular arthrodesis<br>The system may be used in adult patients. | | Clinical studies | Clinical studies were not required for this submission | | Animal Study | Animal Study was not required for this submission | | Conclusion | The Airlock® Centrolock® osteosynthesis implant systems are<br>substantially equivalent to the primary predicate device OrthoHelix<br>surgical designs Mini MaxLock Extreme® Plating System (K120157), to the<br>reference Novastep Airlock® osteosynthesis plate systems (K143523), and<br>to the other predicate Wright Medical Technology MICA™ Screw System<br>(K162353) in terms of intended use and indications for use.<br>The Airlock® Centrolock® osteosynthesis implant systems are<br>substantially equivalent to the primary predicate device OrthoHelix<br>surgical designs Mini MaxLock Extreme® Plating System (K120157), to the<br>reference Novastep Airlock® osteosynthesis plate systems (K143523) in<br>terms of material, design and function. | | | Any minor differences between these devices do not raise new questions<br>of safety and effectiveness. | HOW TO JOIN EXCELLENCE Tel. +33 (0)2.00 23 86 50-Fax: +33 (0)2 30 96 2561 1 m p # a = ( 6 p = Sidge Social | Sarroce Lami Entre Perbiners Aphasa + Balinor P + 3300 SANT-GREGORE Coule + FRANCE Tai, +33 (0)2 30 20 AB 50 + Fax : +33 (0)2 30 98 81 wire Fris fol 752 290 791 - 7122 2502 787 FC3 Perces {4}------------------------------------------------ novastep - 5 315 a D Espace Performance Alphasis - Bliliment P - 35789 SAINT-OREGOIRE Car FRANCE 16 61 SAS and creption of the 129 032 xi : Cube A.P.E. 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