(105 days)
Not Found
No
The 510(k) summary describes a mechanical plating system for orthodontic anchoring and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a plating system used as an anchor in orthodontic procedures, which is a structural component rather than a device that delivers therapy.
No
The device is described as a plating system used as an anchor in orthodontic procedures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "plating system," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "plating system intended to be placed in the mouth, for use as an anchor in orthodontic procedures." This describes a device used in vivo (within the body) for a structural purpose.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The Stryker Leibinger Skeletal Anchoring System is a surgical implant used directly in the patient's mouth, not a device used to test samples in a lab.
N/A
Intended Use / Indications for Use
The Stryker® Leibinger Universal Skcletal Anchoring System is a plating system intended to he placed in the mouth f be placed in the mouth for use as an anchor in orthodontic procedures.
Product codes
DZE
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
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
$50 $ 0 2016
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Leibinger Skeletal Anchoring System
OnyxCeph\u00ae Ectoiniger Skeletal Anchor
| General Information | |
|---|---|
| Proprietary Name: | Stryker® Leibinger Skeletal Anchoring System |
| Common Name: | Endosseous Implant |
| Proposed Regulatory Class: | Class III |
| Device Classification: | DZE (872.3640) |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 269-323-4226 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie |
| Associate Manager RA QA | |
| Phone: 269-323-4226 | |
| Fax: 269-323-4215 | |
| Summary Preparation Date: | June 4, 2004 |
Intended Usc
The Stryker® Leibinger Universal Skcletal Anchoring System is a plating system intended to
he placed in the mouth f be placed in the mouth for use as an anchor in orthodontic procedures.
Substantial Equivalency Information
The Stryker® Leibinger Skeletal Anchoring System is substantially equivalent to legally marketed K033483 KLS-Martin Ortho Anchorage System is Substantially Tequivalent for System.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the department's logo, which is a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top and left side of the circle.
Public Health Service
SEP 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wade T. Rutkoskie Regulatory Affairs Associate Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49024
Re: K041651
Trade/Device Name: Stryker Leibinger Skeletal Anchoring System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: September 21, 2004 Received: September 23, 2004
Dear Mr. Rutkoskie:
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
Page 2 - Mr. Rutkoskie
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/dsma/dsmamain.html
Sincerely yours,
Cure
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
Indications for Use
510(k) Number (if known): K041651
Device Name: Stryker Leibinger Skeletal Anchoring System
Indications For Use:
The Stryker Leibinger Skeletal Anchoring System is a plating system intended to be placed in the mouth, for use as an anchor in orthodontic procedures.
Prescription Use X (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)
Robert S. Botros, M.D. Susan Renner
Division Director
y, General Hospital, Division of Anesthesiolo Infection Control, Dental I
510(k) Number: K04165