(112 days)
Not Found
No
The device description and intended use clearly define a mechanical plate and screw system for orthodontic anchoring, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is used as an anchor for orthodontic procedures, which are cosmetic or structural corrections, not for treating any disease or injury.
No.
The "Intended Use / Indications for Use" states that the device is intended to be used as an anchor for orthodontic procedures, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a "plate and screw system" designed to be implanted, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be implanted intraorally and used as an anchor for orthodontic procedures." This describes a device used in vivo (within the body) for a structural and mechanical purpose.
- Device Description: The description details a "plate and screw system designed to be implanted intraorally." This further reinforces its use within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Orthodontic Bone Anchor System does not involve any such testing of biological samples.
Therefore, the Orthodontic Bone Anchor System is a medical device used for a therapeutic/structural purpose within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures.
Product codes
OAT
Device Description
The Synthes (USA) Orthodontic Bone Anchor System is a plate and screw system designed to be implanted intraorally and used as an anchor for orthodontic procedures. The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mm cortex screws and 1.85 mm emergency screws. The plate anchors are offered in various designs for attachment to the orthodontic device. The screw anchor portion of the system consists of 1.55 mm self-drilling and self-tapping screw anchors which incorporate a non-threaded gingival collar beneath the screw head which protects the soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraorally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| Contact: | Deborah L Jackson, RAC | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6948 | ||
| MAR 08 2007 | ||
| Device Name: | Synthes Orthodontic Bone Anchor System | |
| Classification: | Class II, §872.3640 - Endosseous Implant Screw | |
| Class II, §872.4760 - Bone plate | ||
| Class II, §872.4880 - Intraosseous fixation screw or wire | ||
| Predicate Device: | KLS-Martin Ortho Anchorage System - Screw Anchors K033483 | |
| KLS Martin Ortho Anchorage System - Plate Anchors K040891 | ||
| Device Description: | The Synthes (USA) Orthodontic Bone Anchor System is a plate | |
| and screw system designed to be implanted intraorally and used as | ||
| an anchor for orthodontic procedures. The plate anchor portion of | ||
| the system consists of T-shaped plate anchors which are attached to | ||
| the bone via 1.55 mm cortex screws and 1.85 mm emergency | ||
| screws. The plate anchors are offered in various designs for | ||
| attachment to the orthodontic device. The screw anchor portion of | ||
| the system consists of 1.55 mm self-drilling and self-tapping screw | ||
| anchors which incorporate a non-threaded gingival collar beneath | ||
| the screw head which protects the soft tissue. | ||
| Intended Use: | The Orthodontic Bone Anchor (OBA) System is intended to be | |
| implanted intraorally and used as an anchor for orthodontic | ||
| procedures. | ||
| Substantial | Information presented supports substantial equivalence. |
Equivalence:
and the comments of the comments of
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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
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