(89 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts in the provided text.
No.
The device is used as a temporary anchor for orthodontic treatment, which is a structural support function rather than a direct therapeutic intervention for a disease or condition.
No
The device, an orthodontic mini screw, is used for anchorage during orthodontic treatment (a therapeutic procedure), not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw made of Titanium 6Al-4V alloy, intended for physical implantation. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- ORLUS mini screw Function: The ORLUS mini screw is a physical device implanted into the bone (maxilla and mandible) to provide anchorage for orthodontic treatment. It is used within the body (in vivo) and does not perform any diagnostic tests on bodily samples.
The description clearly states its purpose is to provide a fixed anchorage for orthodontic movement of teeth, which is a mechanical function within the body, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
II
Device Description
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.6 and 1.8 mm in diameter and range from 5-14mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
ORLUS mini screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations. An extensive review of literature pertaining to the safety and biocompatibility of ORLUS mini screw has been conducted. Appropriate safeguards have been incorporated in the design of ORLUS mini screw.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '050568'. The numbers are written in a slightly slanted manner, and the overall image has a simple, unadorned appearance.
JUN 1 - 2005
ORLUS MINI SCREW
ORTHOLUTION
Fax: +82 2 478-0735 & +82 2 483-1212
Ortholution Co.,Ltd.
#416-1, Room 207, Duchon B/D., Seongnae-dong, Gangdong-ku, Seoul, Korea www.ortholution.com
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 24, 2005
-
- Company making the submission:
| Company | |
|---|---|
| Name | Ortholution Co., Ltd. |
| Address | 207 Dunchon B/D., #416-1 Seongnae-Dong, |
| Gangdong-Gu, Seoul, Korea | |
| Phone | |
| Fax | |
| Contact | |
| Internet | + 82 2-483-1212 |
- 82 2-478-0735
J. M. Kim / president
Doldol22@netian.com |
-
- Device:
Proprietary Name – ORLUS mini screw Common Name – Small bone screw Classification Name - Endosseous dental implant
- Device:
3. Predicate Device:
Osterned Orthodontic Screw System, OsteoMed L.P., K031936 Dual Top Anchor System Screws, Jeil Medical Corporation, K033767
-
- Classifications Names & Citations:
21CFR 872.3640, DZE, Endosseous dental implant, Class2
- Classifications Names & Citations:
-
- Description:
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.6 and 1.8 mm in diameter and range from 5-14mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
- Description:
009007
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters that appear to be alphanumeric. The string reads 'kcs0568'. The characters are written in a cursive style, with some connections between the letters and numbers. The writing is dark against a lighter background.
Ortholution Co.,Ltd.
ORLUS MINI SCREW
#416-1, Room 207, Duchon B/D., Seongnae-dong, Gangdong-ku, Seoul, Korea Fax: +82 2 478-0735 www.ortholution.com *822483-1212
6. Indication for use:
The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
7. Contra-indications:
-
- Osteoporosis
-
- Advanced diabetes
- Metal allergies 3)
-
- Review:
ORLUS mini screw has the same device characteristics as the predicate device. Material, design and use concept is similar.
ORLUS mini screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of ORLUS mini Appropriate safeguards have been incorporated in the design of screw has been conducted. ORLUS mini screw.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Ortholution Co., Ltd. concludes that ORLUS mini screw is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
-
Ortholution Co., I.td. will update and include in this summary any other information deemed 10 reasonably necessary by the FDA.
END
020088
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 - 2005
Ortholution Company Limited C/O Ms. Cathryn N. Cambria Consultant Arkin Consulting Group, LLC 1733 Canton Lane Marietta, Georgia 30062
Re: K050568
Trade/Device Name: Orlus Mini Screw Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: DZE Product Code: II Dated: May 9, 2005 Received: May 11, 2005
Dear Ms. Cambria:
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 (1 112 ), it nay ob of of other of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Cambria
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 modi that I Dr mas made a statutes and regulations administered by other Federal agencies. or the Act of any I ederal bact's requirements, including, but not limited to: registration 1 od Intilet compry with 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT Fart 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ijon 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) I mis letter wifi and in J . 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), If you desire specific at 110 to pliance 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 may outain 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,
Sylvie Y. Michaud D.M.D.
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
4
Page 1 of 1
Indications for Use
510(k) Number (if known): KO50568
Device Name: Orlus Mini Screw
Indications for Use:
The Orlus Mini Screw is intended for use as a temporary anchor for orthodontic treatment.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Swarn Sunne
(Division Sicn-Off) Division of Anesther angy, General Hospital, Intection Control, Denal Devices
510(k) Number _