(246 days)
The Arthrex Opening Wedge Osteotomy System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.
The Arthrex Opening Wedge Osteotomy System includes the following basic components: a guide system, osteotomes, a forked-wedge tool for opening the wedge, and a set of bone plates for maintaining the wedge opening. The osteotomy plates are made of surgical grade stainless steel.
This document is a 510(k) premarket notification for the Arthrex Opening Wedge Osteotomy System. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- The number or qualifications of experts for ground truth.
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- The sample size for a training set.
- How ground truth for a training set was established.
This is a regulatory submission for a surgical instrument system, relying on the substantial equivalence pathway, which typically involves comparing the device's technical characteristics and intended use to an already legally marketed predicate device rather than conducting new performance studies against specific acceptance criteria like those found in AI/ML device submissions.
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JUN 10 1998
510(k) Summary
9/26/97
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. DurlacherDirector of Regulatory Affairs and Quality Assurance (ext. 117) |
Arthrex Opening Wedge Osteotomy System Trade Name: Common Name: Bone Plate and Accessories Plate, Fixation, Bone (per 21 CFR 888.3030) Classification:
Description:
There are two schools of thought regarding osteotomy methods: the closing wedge method, and the opening wedge method, in the closing wedge method, removal of a bone wedge creates an angled gap in the bone. Part of the bone is left as a hinge at the apex of the angle. The hinge allows the gap to narrow and the bone material on either side of the closed gap joins together.
In the opening wedge method, a cut is made across the bone. Part of the bone is left as a hinge, as in the closing wedge method. In contrast to the closing wedge method, however, the hinge allows the cut gap to open. The open wedge is filled with graft material.
The two methods are performed on opposite sides of the bone to give equivalent results. For example, when a given deformity would be corrected by performing the opening-wedge procedure on the medial side of a bone, an equivalent closing-wedge correction would be performed laterally.
The closing wedge method is the current standard, although several disadvantages are associated with the technique. The most significant disadvantages of the closing wedge method are: (i) disruption of the tibial-femoral joint; (ii) possible damage to neurovascular structures; and, (iii) disruption of the medial cortex, resulting in instability and nonunion between the upper and lower bone because of possible soft tissue interference. It is also difficult to compute the correct amount of bone to remove, and, therefore, several extra cuts may be required.
The opening wedge technique avoids or limits many of the disadvantages associated with the closing wedge-method. Additionally, the medial, open-wedge HTO has the following advantages over the closed, lateral-wedge HTO: (i) simplicity; (iii) ability to quickly change angle at any time during the procedure; and (iv) no fibular osteotomy is required. Nevertheless, only a few surgeons are currently using the opening wedge procedure. This is most likely due to a lack of functional, easy to use instrumentation.
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The Arthrex Opening Wedge Osteotomy System overcomes the disadvantages of the prior art and fulfills the above-described need by providing a bone plate system for performing the opening wedge osteotomy technique. The bone plate system of the present invention includes the following basic components: a guide system, osteotomes, a forked-wedge tool for opening the wedge, and a set of bone plates for maintaining the wedge opening.
The osteotomy plates are made of surgical grade stainless steel, the biocompatibility of which has been well documented.
Intended Use:
The Arthrex Opening Wedge Osteotomy System are intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
The primary differences between the Arthrex and Intermedics bone plates are as follows:
| Intermedics | Arthrex | |
|---|---|---|
| Configuration | "L" shaped plates | "T" shaped and "I" shaped plates |
| Metal Spacer | No | Yes |
| Material | Titanium Alloy | Surgical Grade Stainless Steel |
The configuration of any bone plate should ideally provide both axial and torsional stability. Since each of these designs provides fixation in more than one plane, such stability is guaranteed. The Intermedics technique calls out for the opening resulting from an opening wedge osteotomy to be filled with a combination of cancellous bone and wedges of bone from the Iliac Crest. The Arthrex technique also calls out for the use of wedges of bone; however, the Arthrex plate also has a metal spacer to provide further support. Although the material for the two plates differs, both have proven track records as acceptable implant materials. Surgical Grade Stainless Steel has been and still is commonly used in a number of fixation devices. None of the -aforementioned differences make the Arthrex plates any less safe and effective than the Intermedics plates. Furthermore, they do not raise any different questions regarding safety and effectiveness from the predicate device.
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Image /page/2/Picture/2 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with a staff and intertwined snakes.
JUN 1 0 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott M. Durlacher Director of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
K973812 Re: Arthrex Opening Wedge Osteotomy System Trade Name: Regulatory Class: II Product Code: HRS Dated: May 19, 1998 Received: May 21, 1998
Dear Mr. Durlacher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Scott M. Durlacher
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "Arthrex" in bold, black letters. To the right of the word is a black and white image of a surgical tool. The tool appears to be a type of clamp or scissor-like instrument, commonly used in medical procedures. The logo is simple and professional, likely representing a medical or surgical company.
Indications for Use
The Arthrex Opening Wedge Osteotomy System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign-Off) Dresson of General Restorativ 510(k) 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.