PILONPLATE WITH ANGULAR STABILITY

K052011 · I.T.S. Implantat-Technologie-Systeme GmbH · HRS · Aug 10, 2005 · Orthopedic

Device Facts

• Record ID: K052011
• Device Name: PILONPLATE WITH ANGULAR STABILITY
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Aug 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.

Device Story

Pilonplate with Angular Stability is a titanium bone plate system for distal tibia fracture fixation. System comprises low-profile 4, 6, and 8-hole plates with 4.2mm cancellous self-tapping/head-locking screws and 4.5mm cortical self-tapping screws. Used by orthopedic surgeons in clinical settings to stabilize bone fragments. Plate and screws provide mechanical fixation to support healing of complex intra- and extra-articular fractures, osteotomies, and rotational shaft fractures. Device is implanted surgically; provides structural support to bone during the healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Materials: CP titanium (ASTM F 67-00) for plates; 6-4 alloyed titanium (ASTM F 136-02) for screws. Surface treatment: TIODIZE Type II. Features: Angular stability, self-tapping screws, 4/6/8-hole configurations. Mechanical fixation device.

Indications for Use

Indicated for patients requiring fracture fixation of the distal tibia, including complex intra- and extra-articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures.

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 Pilon Plate (K020602)
• DePuy/Ace TIMAX Pilon Plate (K982347)
• Synthes LCP Distal Tibia Plates (K013248)
• Synthes (USA) Medial Distal Tibia Plates (K001945)
• Link Small Bone Plates (May Anatomical Plate) (K854825)
• Zimmer Periarticular Plating System

Submission Summary (Full Text)

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Koszoll

## 510(k) Summary of Safety and Effectiveness Section XII: SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

AUG 1 0 2005

| 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: | Pilonplate 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 Pilon Plate (K020602)<br>DePuy/Ace TIMAX Pilon Plate (K982347)<br>Synthes LCP Distal Tibia Plates (K013248)<br>Synthes (USA) Medial Distal Tibia Plates (K001945)<br>Link Small Bone Plates (May Anatomical Plate) (K854825)<br>Zimmer Periarticular Plating System |
| DEVICE DESCRIPTION: | The I.T.S. Pilonplate with Angular Stability is a low-profile universal left<br>and right titanium 4, 6, and 8 hole plate with various length 4.2mm<br>Cancellous self-tapping and head locking stabilization screws.<br>Additional 4.5mm Cortical screws of various lengths are self-tapping and<br>secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is<br>made from CP titanium according to ASTM F 67-00 and the screws are<br>made from 6-4 alloyed titanium according to ASTM F 136-02. The plate<br>and screws are surface conditioned with a TIODIZE, Type II preparation. |
| INTENDED USE: | Indications for Use include fixation of complex intra- and extra- articular<br>fractures, osteotomies, high medial malleollar fractures, and low boot top<br>type rotational distal extra-articular shaft fractures of the distal tibia. |
| BASIS OF SUBSTANTIAL<br>EQUIVALENCE: | The I.T.S. Pilonplate with Angular Stability is<br>substantially equivalent to the Synthes, DePuy/ACE, Link America, and<br>Zimmer bone plate systems. |
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The I.T.S. Pilonplate with Angular Stability is shown to be safe and<br>effective for use in fracture fixation of the distal tibia in the leg. |

Section XII

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the circle's perimeter.

## AUG 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.X. Implantat-Technologie-Systeme GmbH c/o Mr. Albert Lippincott III U.S. Agent and Official Correspondent for I.T.S. Implantat-Technologie-Systeme GmbH Engineering Consulting Services, Inc. 3150 E 200th Street Prior Lake, Minnesota 55372

Re: K052011

Trade/Device Name: Pilonplate 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: July 15, 2005 Received: July 25, 2005

Dear Mr. Lippincott:

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 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.

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 (QS) regulation (21 CFR Part 820); 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. Albert Lippincott III

This letter will allow you to begin 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 [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 Division 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,

Stept Rludn
Mark N. Melkerson

N. Melkers Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter

EN ISO 13485

EN ISO 9001

## Indications for Use

KOSZOU 510(k) NUMBER: DEVICE NAME: PILONPLATE WITH ANGULAR STABILITY INDICATIONS FOR USE:

The I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg.

Indications for Use include fixation of complex intra- and extra-

articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.

Prescription Use X 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)

Stipt. Curde
Division Sign-Off

eneral, Restorative and Neurological Developments of CDRH, Office of Device Evaluation (ODE)

510(k) Number K052011