(16 days)
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.
The I.T.S. Pilonplate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 4.5mm Cortical screws of various lengths are self-tapping and secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
The provided text describes a medical device, the "Pilonplate with Angular Stability," and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence to previously marketed devices rather than presenting performance study results against specific criteria.
Therefore, I cannot populate the requested table and answer questions 2 through 9 based solely on the provided text. The document confirms:
- Device Name: Pilonplate with Angular Stability
- Intended Use: 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.
- Substantial Equivalence: The basis of substantial equivalence is to Synthes, DePuy/ACE, Link America, and Zimmer bone plate systems.
- Claim of Safety and Effectiveness: "The I.T.S. Pilonplate with Angular Stability is shown to be safe and effective for use in fracture fixation of the distal tibia in the leg." However, no study data or acceptance criteria are presented to support this claim in this document.
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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 GmbHAutal 28Lassnitzhoehe A-8301AUSTRIA |
|---|---|
| 510(k) FIRM CONTACT: | Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.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 |
| SUBSTANTIALLYEQUIVALENT 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 |
| DEVICE DESCRIPTION: | The I.T.S. Pilonplate with Angular Stability is a low-profile universal leftand right titanium 4, 6, and 8 hole plate with various length 4.2mmCancellous self-tapping and head locking stabilization screws.Additional 4.5mm Cortical screws of various lengths are self-tapping andsecure the Pilonplate to the shaft of the tibia bone. The Pilonplate ismade from CP titanium according to ASTM F 67-00 and the screws aremade from 6-4 alloyed titanium according to ASTM F 136-02. The plateand screws are surface conditioned with a TIODIZE, Type II preparation. |
| INTENDED USE: | Indications for Use include fixation of complex intra- and extra- articularfractures, osteotomies, high medial malleollar fractures, and low boot toptype rotational distal extra-articular shaft fractures of the distal tibia. |
| BASIS OF SUBSTANTIALEQUIVALENCE: | The I.T.S. Pilonplate with Angular Stability issubstantially equivalent to the Synthes, DePuy/ACE, Link America, andZimmer bone plate systems. |
| SUMMARY OF SAFETYAND EFFECTIVENESS: | The I.T.S. Pilonplate with Angular Stability is shown to be safe andeffective 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.