(67 days)
The Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.
The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required.
Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia and distal femur including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
It is intended to be used with adequate post-operative immobilization.
The Arthrex Titanium Opening Wedge Osteotomy System is comprised of plates and screws designed in various sizes to address patient needs. The plates are offered in an A/P sloped tibial plate, a non-sloped tibial plate, and a femoral plate design. The primary feature of the plates is a self-contained locking hole design. The screws are available in a cancellous and cortical design.
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Arthrex Titanium Opening Wedge Osteotomy System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and substantial equivalence, but it does not include details about performance criteria, clinical studies, or technical evaluations with specific metrics.
Therefore, I cannot extract the requested information based on the input provided.
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SFP 22 2003
032187
page 1 of 1
510(k) SUMMARY Arthrex Titanium Opening Wedge Osteotomy System
| NAME OF SPONSOR: | Arthrex, Inc.2885 S. Horseshoe DriveNaples, Florida 34104 |
|---|---|
| 510(K) CONTACT: | Sally Foust, RACRegulatory Affairs SpecialistArthrex, Inc.Telephone: (239) 643-5553 ext. 1251FAX: (239) 430-3494E-mail: sfoust@arthrex.com |
| TRADE NAME: | Arthrex Titanium Opening WedgeOsteotomy System |
| COMMON NAME: | Plates and Screws |
| DEVICE PRODUCT CODE, CFR No. | HRS |
DEVICE PRODUCT CODE, CFR No. HRS 21 CFR 888.3030 & DEVICE CODE
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Titanium Opening Wedge Osteotomy System is comprised of plates and screws designed in various sizes to address patient needs. The plates are offered in an A/P sloped tibial plate, a non-sloped tibial plate, and a femoral plate design. The primary feature of the plates is a self-contained locking hole design. The screws are available in a cancellous and cortical design.
The Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies. The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex Titanium Opening Wedge Osteotomy System is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any differences between the Arthrex Titanium Opening Wedge Osteotomy System and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Arthrex Titanium Opening Wedge Osteotomy System is substantially equivalent to the currently marketed predicate devices.
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Public Health Service
SEP 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust, RAC Regulatory Affairs Specialist Arthrex, Inc. 2885 S. Horseshoe Drive Naples, FL 34104
Re: K032187
Trade/Device Name: Arthrex Titanium Opening Wedge Osteotomy System Regulation Numbers: 21 CFR 888.3030, 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HRS, HWC Dated: July 16, 2003 Received: July 22, 2003
Dear Ms. Foust:
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 - Ms. Sally Foust, RAC
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark M. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K032187
INDICATIONS FOR USE:
The Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.
The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required.
Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia and distal femur including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
It is intended to be used with adequate post-operative immobilization.
OR
Concurrence of CDRH, Office of Device Evaluation
X Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Over-The-Counter
Use
fr. Mark N. Millman
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5100 Number _
§ 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.