ORLUS MINI SCREW

K050568 · Ortholution Co., Ltd. · DZE · Jun 1, 2005 · Dental

Device Facts

• Record ID: K050568
• Device Name: ORLUS MINI SCREW
• Applicant: Ortholution Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orlus Mini Screw is intended for use as a temporary anchor for orthodontic treatment.

Device Story

ORLUS mini screw is a titanium 6Al-4V alloy bone screw used as temporary orthodontic anchorage. Device features dual heads for wire attachment to stabilize maxilla and mandible during tooth movement. Screws range 1.6-1.8 mm in diameter and 5-14 mm in length. Used in clinical dental settings by orthodontists; removed upon completion of treatment. Supplied sterile for single use. Provides fixed anchorage point to facilitate orthodontic tooth movement.

Clinical Evidence

No clinical data. Safety and performance established through bench testing, biocompatibility assessment, and literature review.

Technological Characteristics

Material: Titanium 6Al-4V alloy. Dimensions: 1.6-1.8 mm diameter, 5-14 mm length. Design: Dual-head screw for wire attachment. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use as a temporary orthodontic anchor for patients requiring orthodontic treatment. Contraindicated in patients with osteoporosis, advanced diabetes, or metal allergies.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Osterned Orthodontic Screw System (K031936)
• Dual Top Anchor System Screws (K033767)

Submission Summary (Full Text)

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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: [phone] & [phone]

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

- 1. Company making the submission:

| Company | |
|-------------------------------------|------------------------------------------------------------------------------------|
| Name | Ortholution Co., Ltd. |
| Address | 207 Dunchon B/D., #416-1 Seongnae-Dong,<br>Gangdong-Gu, Seoul, Korea |
| Phone<br>Fax<br>Contact<br>Internet | + 82 2-483-1212<br>+ 82 2-478-0735<br>J. M. Kim / president<br>[e-mail] |

- 2. Device:
Proprietary Name – ORLUS mini screw Common Name – Small bone screw Classification Name - Endosseous dental implant

### 3. Predicate Device:

Osterned Orthodontic Screw System, OsteoMed L.P., K031936 Dual Top Anchor System Screws, Jeil Medical Corporation, K033767

- 4. Classifications Names & Citations:
21CFR 872.3640, DZE, Endosseous dental implant, Class2

- 5. 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.

## 009007

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### Ortholution Co.,Ltd.

ORLUS MINI SCREW

#416-1, Room 207, Duchon B/D., Seongnae-dong, Gangdong-ku, Seoul, Korea Fax: [phone] 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:

- 1) Osteoporosis
- 2) Advanced diabetes
- Metal allergies 3)
- 8. 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.

- 9. 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.

- Ortholution Co., I.td. will update and include in this summary any other information deemed 10 reasonably necessary by the FDA.
END

# 020088

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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 _