The proposed OrthoFix Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

Device Description

The OrthoFix Screw is fabricated from titanium Alloy, which meets the material requirements specified in the ASTM standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the OrthoFix Screw in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head for screwing the OrthoFix Screw with an instrument, insertion handle tip that is connected to a commercially available insertion handle. The insertion handle tip is manufactured with a medical grade stainless steel 316L. The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed OrthoFix Screw is threaded for quick insertion and provides stability and bio mechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing to aid the orthodontist in self screwing or self drilling.

AI/ML Overview

The application describes the OrthoFix Screw as an endosseous dental implant intended to provide a fixed anchorage point for orthodontic appliances. The study evaluates the device's mechanical properties through non-clinical testing and compares it to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Predicate Device K033767)	Reported Device Performance (OrthoFix Screw)
Torque value at fracture of the Dual Top Anchor screw of Jeil Medical Corp. (Implicit: demonstrating similar or better performance).	Torque testing demonstrated that the torque value at fracture for the OrthoFix Screw is substantially equivalent to the predicate Dual Top Anchor screw of Jeil Medical Corp.
Ability to withstand loads in typical orthodontic applications (Implicit: exceeding 300 grams max load).	Shear Cut and Tensile Strength (Axial) tests showed that the implant was able to withstand loads close to 80kg without presenting any kind of damage, which is well above the 300grs maximum load present in typical orthodontical applications.
Material: Medical Grade Titanium Alloy (ASTM 136-98 or equivalent).	Material: Medical Grade Titanium Alloy (ASTM 136-08).
Design (incorporates a recess, through hole, tapered collar, self-drilling/self-tapping thread)	Design (incorporates a recess, through hole, tapered collar, self-drilling/self-tapping thread.
Principle of Operation: Provide fixed anchorage for orthodontic movement of teeth.	Principle of Operation: Provide fixed anchorage for orthodontic movement of teeth.
Indications for Use: Fixed anchorage for orthodontic appliances, temporary use, single-use only, for adolescents greater than age 12 and adults.	Indications for Use: Fixed anchorage for orthodontic appliances, temporary use, single-use only, for adolescents greater than age 12 and adults.
Sterility: Provided as non-sterile (for predicate K033767, another predicate K093299 is also non-sterile).	Sterility: Provided as sterile. (Note: This is a difference from the comparator, but likely deemed acceptable as sterility is generally a positive attribute).

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample size for the mechanical tests. It refers to "Torque testing performed on the OrthoFix Screw" and "Shear Cut and Tensile Strength (Axial) tests." It can be inferred that a sufficient number of devices were tested to draw the reported conclusions, but no specific count is provided.

The data provenance is not specified (e.g., country of origin). The testing described is non-clinical laboratory testing, not human study data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable to the provided study. The study focuses on non-clinical mechanical testing, not a clinical assessment requiring human expert ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the study involves non-clinical mechanical testing, not clinical diagnosis or interpretation that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study presented is a non-clinical mechanical performance comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this is a medical device (screw) and not an AI algorithm. Therefore, "standalone" performance in the context of AI is not applicable. The device's performance is inherently "standalone" in that it performs its mechanical function independently. However, its clinical effectiveness is always in conjunction with a human orthodontist.

7. The Type of Ground Truth Used:

For the mechanical tests, the "ground truth" used was the mechanical properties and performance of the predicate device (Jeil Medical Corp.'s Dual Top Anchor System Screw, K033767) as a benchmark for substantial equivalence, along with established engineering standards and expected forces in orthodontic applications (e.g., 300grs maximum load).

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this type of medical device.

Summary

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SECTION 3

K113652J

510(k) Summary

3 2012

ОСТ

Device Name:	OrthoFix Screw
Date Prepared:	September 15, 2011
Sponsor:	BONAFIX Surgical and Dental Implants, LLC118 W Prive Cr.Delray Beach Fl, 33445
Contact:	Juan TezakJuan@Bonafixsdi.com(561) 789-2411
Product Code:	OAT
ClassificationName:	Class II
ClassificationPanel:	Dental
RegulationNumber:	872.3640
Common Name:	Endosseous Dental Implant

Common Name: Endosseous Dental Implant

Predicate Devices:

Screw Anchor of the SYNTHES Orthodontic Bone Anchor . System; SYNTHES (USA) - (reference 510(k) K093299 determined substantially equivalent on December 16, 2010).
Dual Top Anchor System Screw; Jeil Medical Corp. -. (reference 510(k) K033767, determined substantially equivalent on February 24, 2004).
Device

Description: The OrthoFix Screw is fabricated from titanium Alloy, which meets the material requirements specified in the ASTM standard ASTM F-136-08. The head on the proximal

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•

portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the OrthoFix Screw in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head for screwing the OrthoFix Screw with an instrument, insertion handle tip that is connected to a commercially available insertion handle. The insertion handle tip is manufactured with a medical grade stainless steel 316L. The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed OrthoFix Screw is threaded for quick insertion and provides stability and bio mechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing to aid the orthodontist in self screwing or self drilling.

Intended

Use: '

Non-ClinicalTest Data:	Torque testing performed on the OrthoFix Screw demonstratedthat the torque value at fracture for the OrthoFix Screw issubstantially equivalent to the predicate Dual Top Anchor screw ofJeil Medical Corp.
Additionally, Shear Cut and Tensile Strength (Axial) tests showedthat the implant was able to withstand loads close to 80kg withoutpresenting any kind of damage, well above the 300grs maximumload present in typical orthodontical applications.

Substantial Equivalence to Predicate Devices:

The proposed OrthoFix Screw is substantially equivalent to predicates devices identified above in terms of indications, principles of operation. design, geometry and materials. The table that follows provides additional details on the equivalence of the three devices

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Comparison of the Proposed OrthoFix Screw to Predicate Devices
Device Name	Predicate Screw Anchor of theSYNTHES Orthodontic BoncAnchor System SYNTHESUSA	Predicate Dual Top AnchorSystem Screw Jeil MedicalK033767	Proposed OrthoFix ScrewBonaFix Surgical & DentalImplants, LLCThis Submission
510(k)Material	K093299Medical Grade Titanium AlloyASTM Std. unknown	Medical Grade Titanium Allov(ASTM 136 98)	Medical GradeTitanum AlloyASTM 136 08)
DesignScrew HeadNeckCollarThread	Hex tupeThrough holeRegularSelf Drilling andSelt Tapping	Incorporates a recessThrough holeTaperedSelf Drilling and Self Tapping	Incorporates a recessThrough holeTaperedSelf Drilling and self Tapping
Principle of Operation	Provide fixed anchorage fororthodontic movement of tecth	Provide fixed anchorage fororthodontic movement of teeth	Provide fixed anchorage fororthodontic movement of teeth
SizesDiameterLengthIndications for Use	l .55 mm6 and 8 mmThe orthodontic Bone AnchorSystem Screw Anchors aremended to be implantedintraorally for orthodonticprocedures in adolescentsgreater than age 12 and adults	1 4, 1 6 & 2.0 mm6. 8. 10 & 12 mmThe device is intended toprovide fixed anchorage pointfor attachment of orthodonticappliances to facilitate theorthodontic movement of teeth.It is used temporarily and isremoved after orthodontictreatment has been completedScrews are intended for singleuse only. For use in adultsover the age of 12	1 6 and 1.8 mm6, 9 and 11 mmThe device is intended toprovide fixed anchorage pointfor attachment of orthodonticappliances to facilitate theorthodontic movement of teeth.It is used temporarily and isremoved after orthodontictreatment has been completed.Screws are intended for singleuse only For use inadolescents greater than age 12and adults
Single useSterility	YesProvidedNon sterile	YesProvidedNon sterile	YesProvidedsterile

Conclusion:

The information provided demonstrates that the proposed device is substantially equivalent to the identified predicate devices.

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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

3 2012

OCT

Mr. Juan Tezak President Bonafix Surgical and Dental Implants, Limited Liability Company 118 West Prive Circle Delray Beach, Florida 33445

Re: K113650

Trade/Device Name: OrthoFix Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: September 20, 2012 Received: September 26, 2012

Dear Mr. Tezak:

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.

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Page 2- Mr. Tezak

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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SECTION 2

Indications for Use

510(k) Number (if known): K113650

Device Name: OrthoFix Screw

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113652

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.