(20 days)
Not Found
No
The summary describes a mechanical bone screw and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for "indirect stabilization of fractures of the maxilla and/or the mandible," which is a therapeutic purpose.
No
The device description clearly states it is a bone screw for temporary fixation and stabilization of fractures, which are treatment functions, not diagnostic ones.
No
The device description clearly describes a physical bone screw, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Lorenz Self-Drilling IMF Screw is a physical implant used for temporary fixation of bones (maxilla and mandible) during fracture healing. It is surgically implanted and does not interact with or analyze biological specimens.
The device's function is mechanical and structural, not diagnostic.
N/A
Intended Use / Indications for Use
The Lorenz Self-Drilling IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.
Product codes
DZE
Device Description
The Self-drilling IMF bone screw for maxillomandibular fixation is 2.0mm in diameter and the thread lengths may range from 5mm - 11mm. The head has a relief groove which may or may not have a hole in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and mandible
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
Not Found
Key Metrics
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/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 - 2005
Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K040983
Trade/Device Name: Lorenz Self-Drilling IMF Screws Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 13, 2004 Received: April 15, 2004
Dear Ms. Reed:
This letter corrects our substantially equivalent letter of April 15, 2004 regarding the incorrect product code of Lorenz Self-Drilling IMF Screws.
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 (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 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.
1
Page- Ms. Reed
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 continue 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,
Sudie Michael md.
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
2
K040983
TAB 2 - Summary of Safety and Effectiveness
510(k) Summary (per 21 CFR 807.92(c))
SUBMITTER
Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218 FDA Registration No. 1032347
MAY - 5 2004
PRODUCT NAME
Common/Usual Name: Bone Screw Proprietary Name: Lorenz Self-Drilling IMF Screw
DEVICE CLASSIFICATION
The FDA has cleared radiographic markers via 510(k) Premarket Notification as Product Code DZL and Classification number 872.4880 Screw, Fixation, Intra osseous - Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for implantable radiographic markers.
PREDICATE DEVICE
The predicate device is the Lorenz IMF Screw cleared under W. Lorenz 510(k) number K983728 on May 13, 1999.
DESCRIPTION OF DEVICE
The Self-drilling IMF bone screw for maxillomandibular fixation is 2.0mm in diameter and the thread lengths may range from 5mm - 11mm. The head has a relief groove which may or may not have a hole in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible.
INTENDED USE OF THE DEVICE
The Lorenz Self-Drilling IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the moxil a aud/or the mandible.
STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES
Both the new and the old devices consist of non absorbable material (titanium) listed in FDA 's Biomaterials Compendium and list of FDA recognized standards. Roth the predicate devices and the modified devices are implanted into bone during surgical procedures to provide temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. The metallic materials and intended use are technically equivalent.
CONCLUSIONS
The use of modified IMF screws and the predicate IMF screws is substantially similar.
3
Indications for Use
510(k) Number (if known): K040983
Device Name:
Indications for Use:
The Lorenz Self-Drilling IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runn
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of
510(k) Number:_
(Posted November 13, 2003)