Ortholock Anchorage Devices

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Craniofacial Technologies, Inc. % Michael Nilo President and Principal Consultant Nilo Medical Consulting Group 3419 Denny Street Pittsburgh, Pennsylvania 15201 Re: K202691 Trade/Device Name: Ortholock Anchorage Devices Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: March 25, 2022 Received: March 28, 2022 Dear Michael Nilo: 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. {1}------------------------------------------------ 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. 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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 medical devices and radiation-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. Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202691 Device Name Ortholock Anchorage Devices Indications for Use (Describe) The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only. | Type of Use (Select one or both, as applicable) | | | |--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------| | <table><tr><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | Prescription Use (Part 21 CFR 801 Subpart D) | | | | Over-The-Counter Use (21 CFR 801 Subpart C) | | | > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # 510k Summary Ortholock Anchorage Devices Prepared: April 28, 2022 Name and Address: Craniofacial Technologies Inc. 98 Buckskin Rd West Hills, California 91307 Contact Person: Kevin Kaveh Email: kevin@craniofacialtech.com Telephone: (818)-282-6677 Name of device: Ortholock Anchorage Devices Classification Name: orthodontic implants CFR: 21 CFR 872.3640 Primary Product Code: OAT ## Device Description: The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances. The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified. | Part. No. | Total Length | Neck<br>Length | Diameter | Color | |-----------|--------------|----------------|----------|-------| | OL011 | 11.5mm | 2.2mm | 1.8mm | Green | | OL013 | 13.5mm | 4.2mm | 1.8mm | Blue | The following table describes the two versions of Ortholock: Orthodontic microimplants are used for the anchorage of orthodontic appliances to treat malpositioned teeth. Ortholock is inserted in the hard palate into each of the two insertion apertures of the appliance accessory with corresponding internal threads for Ortholock's external locking threads. The appliance accessory includes a tube for the attachment of 1.1 mm orthodontic round wire. Ortholock is intended for temporary use during orthodontic treatment. The device is single use only. Indications for Use: The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only. Testing Summary: Ortholock was compared to the primary predicate device in bench testing using protocols based on ISO 19023 and ASTM F543-17 for torsional properties, driving torque, axial pullout {4}------------------------------------------------ strength, and self-tapping performance. The test results of these tests demonstrated that similar mechanical performance values could be achieved by the subject and primary predicate device. Ortholock Anchorage Device is provided Non-Sterilized by end user). Sterilization by moist heat was validated by ISO 17665-1. Biological assessment has been performed according to ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", for the subject devices. Cytotoxicity testing according to ISO 10993-5 Biological Evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity. Primary Predicate Device: The C-Type and Special Type Orthodontic Anchor Screws (K063495) Biomaterials Korea ## Reference Device: PSM Medical BENEFIT Screw - (K110392) ### Substantial Equivalence: | | Subject Device | Primary Predicate<br>Device | Reference Device | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Ortholock Anchorage<br>Devices<br>Craniofacial Technologies<br>(K202691) | The C-Type, CT Type<br>and Special Type<br>Orthodontic Anchor<br>Screws K063495<br>Biomaterials Korea | PSM Medical BENEFIT Screw<br>– (K110392) | | Indications for<br>Use | The Ortholock Anchorage<br>Devices are intended to<br>provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of teeth in<br>adolescents greater than<br>12 years of age and<br>adults. The devices are<br>used temporarily and are<br>removed after<br>orthodontic treatment<br>has been completed.<br>Screws are intended for<br>single use only. | Intended for use as a<br>temporary anchor<br>for orthodontic<br>treatment | The PSM LOMAS / BENEFIT<br>Screws are intended to<br>provide a fixed anchorage<br>point for attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of teeth in<br>adolescents greater than 12<br>years of age and adults.<br>Screws are intended for<br>single use only. | {5}------------------------------------------------ | Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Surface<br>Treatment | Anodized | Anodized | Anodized | | Design | Image: Ortholock screw and blue attachment | Image: Ortholock screw | Image: Ortholock screw and attachment | | Body Diameter | 1.8mm | 1.8mm | 2.0mm and 2.3mm | | Head Structure | Externally Threaded<br>Head for the attachment<br>of orthodontic appliances | Bracket head for the<br>attachment of<br>orthodontic<br>appliances (extra<br>long neck also<br>facilitates the<br>attachment of<br>orthodontic<br>appliances) | Internally Threaded Head<br>for the attachment of<br>orthodontic appliances | | Length | Threaded Body: 7.4mm<br>Smooth Neck: 2.2mm<br>and 4.2mm<br>Head: 1.9mm<br>Overall Length: 11.5mm<br>and 13.5mm | Threaded Body:<br>7mm<br>Smooth Neck: 4mm<br>and 6mm<br>Head: 2.1mm<br>Overall Length:<br>13.1mm and<br>15.1mm | Available in threaded<br>lengths of 7mm, 9mm,<br>11mm, and 13mm. | | Placement<br>Locations | Suitable locations for<br>Ortholock placement<br>include the paramedian<br>or midsagittal region<br>of the hard palate and<br>the anterior palate. Do<br>not place the Ortholock<br>Anchorage Device screws<br>in the sutures of people<br>with developing bone or<br>sutures that are<br>not completely fused. | Multiple locations in<br>the oral cavity. | Multiple locations in the<br>oral cavity. | | Non-Sterile<br>(Sterilized before<br>use) | Yes | Yes | Yes | | Sterilization<br>Validation<br>Provided | Yes | Yes | Yes | | Principles of<br>Operation | Orthodontic implants are<br>used for the anchorage<br>of orthodontic appliances<br>to treat malpositioned<br>teeth. The head of the<br>screw contains an<br>external thread for the<br>attachment of<br>orthodontic appliances<br>for temporary use during<br>orthodontic treatment. | Orthodontic<br>implants are used for<br>the anchorage of<br>orthodontic<br>appliances to treat<br>malpositioned teeth.<br>The head of the<br>microimplant<br>contains a slot<br>feature for the<br>attachment of<br>orthodontic<br>appliances for<br>temporary use<br>during orthodontic<br>treatment. | Orthodontic implants are<br>used for the anchorage of<br>orthodontic appliances to<br>treat malpositioned teeth.<br>The head of the PSM<br>Medical Benefit<br>microimplant contains an<br>internal thread for the<br>attachment of orthodontic<br>appliances for temporary<br>use during orthodontic<br>treatment. | {6}------------------------------------------------ Conclusion: Ortholock Anchorage Screws are substantially equivalent to the Biomaterials Korea C-Type, CT Type and Special Type Orthodontic Anchor Screws because they have substantially similar indications, are intended for the same use, are made from the same materials, and have the same principle of operations. They are both sold non-sterilized by the user, both are self-drilling, and have similar testing including sterilization and bench testing. Comparative bench testing shows their mechanical characteristics are similar. Their diameters, lengths, smooth neck lengths, and head sizes are similar. The head design of the subject device is similar to the head design of the reference device-the PSM Medical BENEFIT Screw. In both the proposed device, orthodontic appliances intended for the same use are firmly anchored to the screw head with the use of threads and similar appliance accessories.