Who is the manufacturer of ORTHOFIX SCREW?

Bonafix Surgical and Dental Implants, LLC filed the 510(k) submission for ORTHOFIX SCREW (K113650).

What is the FDA product code for ORTHOFIX SCREW?

OAT. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ORTHOFIX SCREW?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ORTHOFIX SCREW?

Screw Anchor of the SYNTHES Orthodontic Bone Anchor System (K093299); Dual Top Anchor System Screw (K033767).

Who can help prepare an FDA 510(k) submission like ORTHOFIX SCREW?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ORTHOFIX SCREW

K113650 · Bonafix Surgical and Dental Implants, LLC · OAT · Oct 3, 2012 · Dental

Device Facts

Record ID	K113650
Device Name	ORTHOFIX SCREW
Applicant	Bonafix Surgical and Dental Implants, LLC
Product Code	OAT · Dental
Decision Date	Oct 3, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

OrthoFix Screw is a titanium alloy endosseous dental implant providing fixed anchorage for orthodontic appliances. Device features a proximal head with a recess for wire attachment, a square indentation for insertion via a handle, a neck with a through-hole for wire fixation, a tapered collar for soft tissue protection, and a threaded distal portion for self-drilling/self-tapping insertion. Operated by orthodontists in a clinical setting. Device is inserted into the jaw to provide stable biomechanical retention for tooth movement; removed upon treatment completion. Benefits include temporary, stable anchorage to facilitate orthodontic correction.

Clinical Evidence

Bench testing only. Torque testing demonstrated fracture values equivalent to the predicate Dual Top Anchor screw. Shear cut and tensile strength testing confirmed the implant withstands loads up to 80kg, exceeding the 300g maximum load typical in orthodontic applications.

Technological Characteristics

Material: Titanium alloy (ASTM F-136-08). Design: Self-drilling/self-tapping threaded screw with proximal recess, through-hole neck, and tapered collar. Dimensions: 1.6-1.8mm diameter; 6, 9, 11mm lengths. Energy source: Manual insertion. Sterilization: Provided sterile.

Indications for Use

Indicated for adolescents >12 years and adults requiring fixed anchorage for orthodontic tooth movement. Used temporarily and removed post-treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Screw Anchor of the SYNTHES Orthodontic Bone Anchor System (K093299)
Dual Top Anchor System Screw (K033767)

Related Devices

K103105 — ORTHODONTIC SCREW · Osstem Implant Co., Ltd. · Mar 25, 2011
K191041 — Orthodontic Fixation Screw [Smart Anchor Miniscrew] · Gni Co., Ltd. · Aug 28, 2020
K202790 — Syntec Orthodontic Mini Screw Extended System · Syntec Scientific Corporation · Sep 17, 2021
K211992 — Ortho MI System · Osteonic Co., Ltd. · Oct 15, 2021
K110275 — ORTHO EASY PIN · Forestadent Bernhard Forster GmbH · Jun 3, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ # bonafix Page 11 of 94 ## SECTION 3 K113652J # 510(k) Summary ### 510(k) Summary 3 2012 ОСТ | Device Name: | OrthoFix Screw | |--------------------------|----------------------------------------------------------------------------------------| | Date Prepared: | September 15, 2011 | | Sponsor: | BONAFIX Surgical and Dental Implants, LLC 118 W Prive Cr. Delray Beach Fl, 33445 | | Contact: | Juan Tezak Juan@Bonafixsdi.com (561) 789-2411 | | Product Code: | OAT | | Classification Name: | Class II | | Classification Panel: | Dental | | Regulation Number: | 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 {1}------------------------------------------------ • 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: ' 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. | Non-Clinical Test Data: | Torque testing performed on the OrthoFix Screw 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. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Additionally, 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, well above the 300grs maximum load 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 {2}------------------------------------------------ bongfix | Comparison of the Proposed OrthoFix Screw to Predicate Devices | | | | | | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Device Name | Predicate Screw Anchor of the SYNTHES Orthodontic Bonc Anchor System SYNTHES USA | Predicate Dual Top Anchor System Screw Jeil Medical K033767 | Proposed OrthoFix Screw BonaFix Surgical & Dental Implants, LLC This Submission | | | | 510(k) Material | K093299 Medical Grade Titanium Alloy ASTM Std. unknown | Medical Grade Titanium Allov (ASTM 136 98) | Medical Grade Titanum Alloy ASTM 136 08) | | | | Design Screw Head Neck Collar Thread | Hex tupe Through hole Regular Self Drilling and Selt Tapping | Incorporates a recess Through hole Tapered Self Drilling and Self Tapping | Incorporates a recess Through hole Tapered Self Drilling and self Tapping | | | | Principle of Operation | Provide fixed anchorage for orthodontic movement of tecth | Provide fixed anchorage for orthodontic movement of teeth | Provide fixed anchorage for orthodontic movement of teeth | | | | Sizes Diameter Length Indications for Use | l .55 mm 6 and 8 mm The orthodontic Bone Anchor System Screw Anchors are mended to be implanted intraorally for orthodontic procedures in adolescents greater than age 12 and adults | 1 4, 1 6 & 2.0 mm 6. 8. 10 & 12 mm The device is intended to provide 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 single use only. For use in adults over the age of 12 | 1 6 and 1.8 mm 6, 9 and 11 mm The device is intended to provide 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 single use only For use in adolescents greater than age 12 and adults | | | | Single use Sterility | Yes Provided Non sterile | Yes Provided Non sterile | Yes Provided sterile | | | Conclusion: The information provided demonstrates that the proposed device is substantially equivalent to the identified predicate devices. : {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ bonafix ## SECTION 2 # Indications for Use ### 510(k) Number (if known): K113650 Device Name: OrthoFix Screw #### Indications For Use: 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. 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