SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM

K093299 · Synthes (Usa) · OAT · Dec 16, 2010 · Dental

Device Facts

• Record ID: K093299
• Device Name: SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
• Applicant: Synthes (Usa)
• Product Code: OAT · Dental
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.

Device Story

System provides fixed intraoral anchorage for orthodontic tooth movement. Components include self-drilling/self-tapping screw anchors (1.55 mm) with non-threaded gingival collars and T-shaped plate anchors (mesh, bracket, or domed designs) fixed with 1.55 mm cortex or 1.85 mm emergency screws. Orthodontic appliances (archwires, elastics, springs) attach to anchor heads or plates. Used by orthodontists in clinical settings. Provides stable skeletal anchorage to facilitate tooth movement, potentially improving treatment outcomes compared to conventional anchorage methods.

Clinical Evidence

Bench testing only. Evaluated resistance to pullout under axial, shear, and cantilever loading. Screws tested for insertion torque, removal torque, and yield/failure torque.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-7Nb) for screws; commercially pure titanium for plates. Principle: Mechanical bone fixation for orthodontic anchorage. Form factor: 1.55 mm diameter screws; T-shaped plates. Non-powered, manual instrumentation.

Indications for Use

Indicated for use as intraoral orthodontic anchors. Screw anchors indicated for adolescents >12 years and adults. Plate anchors indicated for adults.

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

• Synthes Orthodontic Bone Anchor System (K063473)
• Jeil Medical Corporation Dual Top Anchor System Screws (K033767)

Submission Summary (Full Text)

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Ko93299

## DEC 1 6 2010

| 510(k) Summary | | | Page 1 of 2 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Device Name: | Synthes Orthodontic Bone Anchor System | | |
| Date Prepared: | July 30, 2010 | | |
| Sponsor: | SYNTHES (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>United States of America | | |
| Contact: | Contact: Alan T. Haley<br>[e-mail]<br>[phone] | | |
| Classification: | Class II, §872.3640, Endosseous dental implant | | |
| Predicate Devices: | Synthes Orthodontic Bone Anchor System (K063473)<br>Jeil Medical Corporation Dual Top Anchor System Screws (K033767) | | |
| Device Description: | The Synthes (USA) Orthodontic Bone Anchor System is intended to be implanted<br>intraorally and used as an anchor for orthodontic procedures. The System includes<br>screw anchors, plate anchors, instruments, and a module case for storage and<br>sterilization. | | |
| | Screw Anchors<br>The screw anchor portion of the system consists of 1.55 mm self-drilling and self-<br>tapping screw anchors which incorporate a non-threaded gingival collar beneath<br>the screw head to protect the soft tissue. Once implanted, orthodontic appliances<br>such as archwires, elastics, and springs can be attached to the head of the anchor.<br><br>The screw anchors are manufactured from titanium alloy (Ti-6Al-7Nb). | | |
| | Plate Anchors<br>The plate anchor portion of the system consists of T-shaped plate anchors which<br>are attached to the bone via 1.55 mm cortex screws and 1.85 mm emergency<br>screws. The plate anchors are offered in three designs (mesh, bracket, and domed)<br>to allow attachment of orthodontic devices such as brackets, archwires, elastics,<br>and springs | | |

The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6Al-7Nb)

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# K093299

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| 510(k) Summary | Page 2 of 2 |
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| Intended Use: | The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be<br>implanted intraorally and used as an anchor for orthodontic procedures in<br>adolescents greater than age 12 and adults.<br><br>The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be<br>implanted intraorally and used as an anchor for orthodontic procedures in adults. |
| Non-Clinical<br>Testing Data: | The Synthes Orthodontic Bone Anchor System was tested for resistance to pullout<br>under clinical loads by means of axial, shear, and cantilever loading. Screws were<br>also tested for insertion torque, removal torque, and yield and failure torque. |
| Substantial<br>Equivalence to<br>Predicate Devices: | The proposed devices are similar to the predicate devices identified above in<br>terms of indications, principles of operation (provide fixed anchorage for<br>orthodontic movement of teeth), device design/geometry, and materials.<br>Information presented supports substantial equivalence. |

(end of summary)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DEC 1 6 2010

Mr. Alan T. Haley CMF Regulatory Affairs Specialist SYNTHES (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K093299

Trade/Device Name: Synthes Orthodontic Bone Anchor System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: December 10, 2010 Received: December 13, 2010

Dear Mr. Haley:

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. Haley

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh 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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Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. The logo and the word "SYNTHES" are the only elements in the image. There is a registered trademark symbol to the right of the word.

Indications for Use

| 510(k) Number (if known): | K093299 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Orthodontic Bone Anchor System |
| INDICATIONS FOR USE: | The Orthodontic Bone Anchor (OBA) System screw anchors are<br>intended to be implanted intraorally and used as an anchor for<br>orthodontic procedures in adolescents greater than age 12 and adults.<br><br>The Orthodontic Bone Anchor (OBA) System plate anchors are intended<br>to be implanted intraorally and used as an anchor for orthodontic<br>procedures in adults. |

Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Roose

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

510(k) Number: K093299