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.

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.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device called "Ortholock Anchorage Devices" and details its equivalence to predicate devices, primarily through bench testing. It does not include information about acceptance criteria for typical AI/ML medical devices, nor does it describe a study with performance metrics in the way these are typically presented for AI/ML device evaluations.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of information for an AI/ML device.

The document focuses on the substantial equivalence of the Ortholock Anchorage Devices to existing predicate devices based on:

Indications for Use: Both the subject device and predicate devices are intended to provide fixed anchorage for orthodontic appliances to facilitate tooth movement in adolescents and adults, for temporary use.
Material: All devices are made from Titanium Alloy.
Surface Treatment: All are anodized.
Principle of Operation: All are orthodontic implants used for anchorage of orthodontic appliances.
Sterilization: All are provided non-sterilized and user-sterilized, with sterilization validated.
Bench Testing: Comparative bench testing was performed for torsional properties, driving torque, axial pullout strength, and self-tapping performance, demonstrating similar mechanical performance values to the primary predicate device (The C-Type and Special Type Orthodontic Anchor Screws, K063495) and having similar characteristics to the reference device (PSM Medical BENEFIT Screw, K110392).

The information provided is for a traditional medical device (orthodontic microimplant), not an AI/ML device, and thus does not include data like sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance for an algorithm, or training set details.

Summary

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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.

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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) 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 (QS) 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 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

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Indications for Use

510(k) Number (if known) K202691

Device Name Ortholock Anchorage Devices

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.

Part. No.	Total Length	NeckLength	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

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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 PredicateDevice	Reference Device
Name	Ortholock AnchorageDevicesCraniofacial Technologies(K202691)	The C-Type, CT Typeand Special TypeOrthodontic AnchorScrews K063495Biomaterials Korea	PSM Medical BENEFIT Screw– (K110392)
Indications forUse	The Ortholock AnchorageDevices are intended toprovide a fixedanchorage point forattachment oforthodontic appliances tofacilitate the orthodonticmovement of teeth inadolescents greater than12 years of age andadults. The devices areused temporarily and areremoved afterorthodontic treatmenthas been completed.Screws are intended forsingle use only.	Intended for use as atemporary anchorfor orthodontictreatment	The PSM LOMAS / BENEFITScrews are intended toprovide a fixed anchoragepoint for attachment oforthodontic appliances tofacilitate the orthodonticmovement of teeth inadolescents greater than 12years of age and adults.Screws are intended forsingle use only.

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Material	Titanium Alloy	Titanium Alloy	Titanium Alloy
SurfaceTreatment	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 ThreadedHead for the attachmentof orthodontic appliances	Bracket head for theattachment oforthodonticappliances (extralong neck alsofacilitates theattachment oforthodonticappliances)	Internally Threaded Headfor the attachment oforthodontic appliances
Length	Threaded Body: 7.4mmSmooth Neck: 2.2mmand 4.2mmHead: 1.9mmOverall Length: 11.5mmand 13.5mm	Threaded Body:7mmSmooth Neck: 4mmand 6mmHead: 2.1mmOverall Length:13.1mm and15.1mm	Available in threadedlengths of 7mm, 9mm,11mm, and 13mm.
PlacementLocations	Suitable locations forOrtholock placementinclude the paramedianor midsagittal regionof the hard palate andthe anterior palate. Donot place the OrtholockAnchorage Device screwsin the sutures of peoplewith developing bone orsutures that arenot completely fused.	Multiple locations inthe oral cavity.	Multiple locations in theoral cavity.
Non-Sterile(Sterilized beforeuse)	Yes	Yes	Yes
SterilizationValidationProvided	Yes	Yes	Yes
Principles ofOperation	Orthodontic implants areused for the anchorageof orthodontic appliancesto treat malpositionedteeth. The head of thescrew contains anexternal thread for theattachment oforthodontic appliancesfor temporary use duringorthodontic treatment.	Orthodonticimplants are used forthe anchorage oforthodonticappliances to treatmalpositioned teeth.The head of themicroimplantcontains a slotfeature for theattachment oforthodonticappliances fortemporary useduring orthodontictreatment.	Orthodontic implants areused for the anchorage oforthodontic appliances totreat malpositioned teeth.The head of the PSMMedical Benefitmicroimplant contains aninternal thread for theattachment of orthodonticappliances for temporaryuse during orthodontictreatment.

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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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.