(93 days)
The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
The Walter Lorenz Surgical Orthodontic Anchorage System is comprised of a variety of plates and screws designed to provide anchorage for orthodontic procedures.
The provided text is a 510(k) summary for the Lorenz Orthodontic Anchorage System. It describes the device, its intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as that data is not present in the provided submission.
The document essentially states that the device is substantially equivalent to previously cleared devices based on its application and function. This type of submission (510(k)) typically relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics like those for a PMA submission or some de novo classifications.
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W. LORENZ
SURGICAL
-- A Biomet Company --
eed. Sr. Requiatory Snecialist
9 2007 FFB
9
510(k) Summary
Trade Name: Lorenz Orthodontic Anchorage System
Classification and Common Name and Reference: Bone Plate CFR 21 872.4760
Product Code: JEY
Device Classification: Class II
The Walter Lorenz Surgical Orthodontic Anchorage System is Device Description: comprised of a variety of plates and screws designed to provide anchorage for orthodontic procedures.
Intended Use: These implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
Commercially Pure Titanium, ASTM F-67 Materials Titanium 6Al 4V Alloy, ASTM F-136
Possible Adverse Effects:
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- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the implant.
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- Migration, bending, fracture or loosening of the implant.
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- Metal sensitivity, or allergic reaction to a foreign body.
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- Decrease in bone density due to stress shielding.
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- Pain, discomfort, abnormal sensation, or palpability due to the presence of the implant.
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- Increased fibrous tissue response around the implant.
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- Necrosis of bone.
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- Inadequate healing.
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- Injury or damage to teeth or periodontal structures.
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- Failure to achieve desired orthodontic result.
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- Undesirable orthodontic result.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain, which may not be related to the implant.
Substantial Equivalence: The Lorenz Orthodontic Anchorage System is believed to be substantially equivalent in application and function to the KLS-Martin Ortho Anchorage System K040891, the Stryker Leibinger Skeletal Anchoring System K041651, the Lorenz Craniofacial/Neuro Bone Plates and Screws 1.0, 1.5 and 2.0mm System K953385 and to the Lorenz IMF and Self-Drilling IMF Screws K983728 and K040983.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim Reed Regulatory Affairs Manager Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218
FFS 9 2007
Re: K063386
Trade/Device Name: Lorenz Orthodontic Anchorage System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 6, 2007 Received: February 7, 2007
Dear Ms. Reed:
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.
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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 (OS) 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,
SperRunger
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
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Indications for Use
510(k) Number (if known):
Device Name: Lorenz Orthodontic Anchorage System
Indications For Use:
The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
AND/OR Prescription Use_ (Part 21 CFR 801 Subpart D)
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)
Page 1 of _
Susan Luprolo
Anesthesiology, General Hospital,
Control, Dental Devices
K0633856
8
§ 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.