CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM

K050852 · I.T.S. Implantat-Technologie-Systeme GmbH · HRS · Jun 22, 2005 · Orthopedic

Device Facts

• Record ID: K050852
• Device Name: CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Jun 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I.T.S. Claviculaplate with Angular Stability is used to stabilize a fracture of the clavicle bone. The system is not intended for spinal use.

Device Story

The I.T.S. Claviculaplate with Angular Stability is a low-profile, universal left/right titanium bone plate system designed for clavicle fracture fixation. The system utilizes cortical and cancellous self-tapping stabilization screws to provide angular stability. The plate is constructed from CP titanium (ASTM F 67-00) and screws from 6-4 alloyed titanium (ASTM F 136-02), both surface-conditioned with a TIODIZE Type II preparation. The device is intended for use by surgeons in clinical settings to stabilize clavicle fractures, malunions, and non-unions, or to perform corrective osteotomies. By providing rigid fixation, the device supports bone healing and restores structural integrity to the clavicle.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: CP titanium (ASTM F 67-00) for plate, 6-4 alloyed titanium (ASTM F 136-02) for screws. Surface treatment: TIODIZE Type II. Design: Low-profile, universal left/right plate with self-tapping stabilization screws. Principle: Angular stability bone fixation. Sterilization: Not specified.

Indications for Use

Indicated for metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the clavicle, including corrective osteotomy and open and closed fractures. Not for spinal use.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Curved Reconstruction Plate (K011334)
• Synthes One-Third Tubular DCL Plate (K011335)
• Acumed Clavicle/Congruent Plate (K012655)
• Synthes Hook Plate

Submission Summary (Full Text)

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K050862

## 510(k) Summary of Safety and Effectiveness Section XII:

| SAFE MEDICAL DEVICES ACT OF 1990<br>510(k) Summary | |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.<br>Autal 28.<br>Lassnitzhoehe A-8301<br>AUSTRIA |
| 510(k) FIRM CONTACT: | Al Lippincott<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372 |
| TRADE NAME: | Claviculaplate with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone |
| | (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: HRS | |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES | Synthes Curved Reconstruction Plate (K011334)<br>Synthes One -Third Tubular DCL Plate (K011335)<br>Acumed Clavicle/Congruent Plate (K012655)<br>Synthes Hook Plate |
| DEVICE DESCRIPTION: | The I.T.S. Claviculaplate with Angular Stability is a low-profile<br>universal left and right titanium plate with various length cortical<br>and/or cancellous self-tapping stabilization screws. The<br>claviculaplate is made from CP titanium according to ASTM F 67-<br>00 and the screws are made from 6-4 alloyed titanium according to<br>ASTM F 136-02. The plate and screws are surface conditioned<br>with a TIODIZE, Type II preparation. |
| INTENDED USE: | The I.T.S. Claviculaplate with Angular Stability is used to stabilize<br>a fracture of the clavicle bone. The system is not intended for<br>spinal use. |
| BASIS OF SUBSTANTIAL<br>EQIVLAENCE: | The I.T.S. Claviculaplate with Angular Stability is substantially<br>equivalent to the Synthes and Acumed bone plate systems. |
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The I.T.S. Claviculaplate with Angular Stability is shown to be safe<br>and effective for use in fracture fixation of the clavicle. |

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from the head.

JUN 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implantat-Technologie-Systeme GmbH C/o Mr. Al Lippincott U.S. Agent and Official Correspondent Engineering Consulting Services Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K050852

Trade/Device Name: Claviculaplate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 28, 2005 Received: April 4, 2005

Dear Mr. Lippincott:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your Bection on (t) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } reletect above and nave acteming marketed predicate devices marketed in interstate commerce use stated in the enerosure/ to regary inter of the Medical Device Amendments, or to devices that provisions of the may 20, 1970, and many of the Federal Food, Drug, and Cosmetic liave been recassified in ace 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 controls provibitions or and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassilion (controls. Existing major regulations affecting your device can be Inay of subject to sublivations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou mate 127 r e issual 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 ally I cueral statutes and regarations as and limited to: registration and listing (21 CFR Part 807); an the Ave Drequirements) ; good manufacturing practice requirements as set forth in the quality laoemig (21 CFR Part 800); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Al Lippincott

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA Intention of succeantal organ mailer 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 If you desire specific auvice for your de needed on on of the regulation entitled.
contact the Office of Compliance at [phone]. "Also, please note them of contact the Office of Compliance at (240) 210 of 20.77.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part - Disco of Small "Misbranding by releiched to premailson is and it the Act from the Division of Small
general information on your responsibilities under the Act from the (800) 6 general information on your responsibilities and its toll-fire number [phone] or 1 Manufacturers, International and Consumer Fibilianses agov/cdrh/industry/support/index.html.

Sincerely yours,

M

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Implant-Technology-Systems GmbH

Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter

Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 [e-mail]

## Indications for Use

510(k) NUMBER: K050852

DEVICE NAME: Claviculaplate with angular stability INDICATIONS FOR USE:

The I.T.S. Claviculatplate with Angular Stability is a titanium implant fracture fixation system for repairing fractures located from the middle third to the distal third of the clavicle.

Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Other indications include corrective osteotomy and open and closed fractures.

The system is not intended for spinal use.

Prescription Use

AND/OR

Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Signature

ivision Sign-Off) Division of C. **1, Restorative and Neurological Devices

510(k) Number K050852

Concurrence of CDRH, Office of Device Evaluation (ODE)

FN 163966 b DVR 093
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