SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM

K063473 · Synthes (Usa) · OAT · Mar 8, 2007 · Dental

Device Facts

• Record ID: K063473
• Device Name: SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
• Applicant: Synthes (Usa)
• Product Code: OAT · Dental
• Decision Date: Mar 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures.

Device Story

Synthes Orthodontic Bone Anchor (OBA) System provides stable anchorage for orthodontic procedures. System comprises T-shaped plate anchors and screw anchors. Plate anchors attach to bone via 1.55 mm cortex screws and 1.85 mm emergency screws; screw anchors are 1.55 mm self-drilling/self-tapping screws featuring non-threaded gingival collars to protect soft tissue. Device implanted intraorally by clinicians. Provides fixed point for orthodontic force application; facilitates tooth movement; improves treatment outcomes by providing skeletal anchorage.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes T-shaped plate anchors and 1.55 mm self-drilling/self-tapping screw anchors. Screws include non-threaded gingival collars. Fixation via 1.55 mm cortex screws and 1.85 mm emergency screws. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients requiring intraoral orthodontic anchorage.

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

• KLS-Martin Ortho Anchorage System - Screw Anchors (K033483)
• KLS Martin Ortho Anchorage System - Plate Anchors (K040891)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold black letters, with a circled "R" symbol next to it. To the right of the word, there is a handwritten code "K06 3473". A horizontal line is present below the word "SYNTHES" and the code.

·

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| | Contact: | Deborah L Jackson, RAC<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone]<br>MAR 08 2007 |
| | Device Name: | Synthes Orthodontic Bone Anchor System |
| | Classification: | Class II, §872.3640 - Endosseous Implant Screw<br>Class II, §872.4760 - Bone plate<br>Class II, §872.4880 - Intraosseous fixation screw or wire |
| | Predicate Device: | KLS-Martin Ortho Anchorage System - Screw Anchors K033483<br>KLS Martin Ortho Anchorage System - Plate Anchors K040891 |
| | Device Description: | The Synthes (USA) Orthodontic Bone Anchor System is a plate<br>and screw system designed to be implanted intraorally and used as<br>an anchor for orthodontic procedures. The plate anchor portion of<br>the system consists of T-shaped plate anchors which are attached to<br>the bone via 1.55 mm cortex screws and 1.85 mm emergency<br>screws. The plate anchors are offered in various designs for<br>attachment to the orthodontic device. The screw anchor portion of<br>the system consists of 1.55 mm self-drilling and self-tapping screw<br>anchors which incorporate a non-threaded gingival collar beneath<br>the screw head which protects the soft tissue. |
| | Intended Use: | The Orthodontic Bone Anchor (OBA) System is intended to be<br>implanted intraorally and used as an anchor for orthodontic<br>procedures. |
| | Substantial | Information presented supports substantial equivalence. |

Equivalence:

and the comments of the comments of

:

.

. - 6 -

:

... ... ... ... ... ... ... ... ..............................................................................................................................................

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah L. Jackson Regulatory Affair Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K063473 Trade/Device Name: Synthes (USA) Orthodontic Bone Anchor System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 26, 2007 Received: February 27, 2007

MAR 0 8 2007

Dear Ms. Jackson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{2}------------------------------------------------

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): 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Clubs

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/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. A horizontal line is present below the word "SYNTHES". A small "R" in a circle is located to the right of the word "SYNTHES".

Indications for Use

1000

| 510(k) Number (if known): | K063473 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Orthodontic Bone Anchor System |
| Indications for Use: | The Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. |

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
|---------------------------------------|---|

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sued Rumer

Page of l 1

av, Clenenal Hospits of Angri on Contoi, De