KLS-MARTIN ORTHO ANCHORAGE SYSTEM

K033483 · KLS-Martin L.P. · DZE · Jan 15, 2004 · Dental

Device Facts

• Record ID: K033483
• Device Name: KLS-MARTIN ORTHO ANCHORAGE SYSTEM
• Applicant: KLS-Martin L.P.
• Product Code: DZE · Dental
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures.

Device Story

KLS-Martin Ortho Anchorage System consists of titanium screws providing rigid skeletal fixation points in the mouth. Device serves as an anchor to facilitate dental movement during orthodontic procedures. Screws are surgically placed by clinicians. System provides stable anchorage, aiding in orthodontic treatment outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Commercially pure (CP) titanium or Ti-6AL-4V titanium alloy. Form factor: Endosseous implant screw. Function: Provides rigid skeletal fixation for orthodontic anchorage.

Indications for Use

Indicated for use as a surgical anchor for orthodontic procedures in patients requiring dental movement.

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

• Centre-Drive Drill Free Screw (K971297)
• Nobel Biocare Onplant Orthodontic System (K980460)

Submission Summary (Full Text)

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JAN 1 5 2004

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## 510(K) SUMMARY

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | |
| Device Name: | KLS-Martin Ortho Anchorage System |
| Trade Name: | Ortho Anchorage System |
| Common Name: | Endosseous Implant Screw |
| Classification<br>Name and Number: | Endosseous Implant (CFR 872.3640) |
| Regulatory Class: | Class III |
| Predicate Devices: | Centre-Drive Drill Free Screw<br>(K971297)<br>Nobel Biocare Onplant Orthodontic System<br>(K980460) |
| Device<br>Description: | The KLS-Martin Ortho Anchorage System consists of<br>a titanium screw designed to aid in dental movement<br>by providing a rigid skeletal fixation point. |
| Intended Use: | The KLS-Martin Ortho Anchorage System is intended<br>to be surgically placed in the mouth for use as an<br>anchor for orthodontic procedures. |

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#### Technological Characteristics:

#### Similarities to Predicate

Screws are similar to KLS-Martin Centre-Drive Drill Free Screw (K971297)

Anchorage screws are either commercially pure (CP) titanium or Ti-6AL-4V Titanium Alloy.

#### Differences to Predicate

KLS-Martin Centre-Drive Drill Free Screw (K971297) is intended for plate fixation across fractures or The Ortho Anchorage System is osteotomies. designed to aid in dental movement by providing a rigid skeletal fixation point.

#### Substantial Equivalence:

The KLS-Martin Ortho Anchorage System is substantially equivalent in application and function to the KLS Martin Centre-Drive Drill Free Screw (K971297)

The KLS-Martin Ortho Anchorage System is THE REO Marantially equivalent in intended use to the Nobel Biocare Onplant Orthodontic System (K980460)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

Ms. Jennifer Damato Director Regulatory Affair Quality Assurance KLS-Marin, L.P. 11239-1 Street Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K033483

Trade/Device Name: KLS-Martin Ortho Anchorage System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: November 3, 2003 Received: November 4, 2003

Dear Ms. Damato:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your securermined the device is substantially equivalent (for the referenced above and have acteringlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce proces that have been reclassified in accordance with the provisions of Amendinens, or to de rough and Cosmetic Act (Act) that do not require approval of a premarket the I cuclar F ood, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provinces of an 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 Mry, it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can or ou found in ther announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Damato

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast be advisod that I Da determination that your device complies with other requirements Incall that I DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally I outstal statis requirements, including, but not limited to: registration r our indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in all qt 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) I mis letter will and w yourse of substantial equivalence of your device to a premarket notification - I 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 [phone] preculation entitled, "Misbranding by reference to premarket notification" (21CFR Part 16 gated on the new obtain other general information on your responsibilities under the Act 607.977. Tourinaly of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Cluts

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): K033483

Device Name: KLS-Martin Ortho Anchorage System

#### Indications For Use:

The KLS-Martin Ortho Anchorage System are screws intended to be surgically placed in The RES Martin Orate anchor for orthodontic procedures in patients.

AND/OR Prescription Use يري (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunno

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(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital. Division Control, Dental Devices

510(k) Number: k083403