(27 days)
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
This Special 510(k) submission is intended to address a line extension to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The line extension involves increasing the distal diameter of the nail. In addition, two shorter length Gamma® Nail Lag Screws will be added to the system. Howmedica Osteonics intends to add the new designs of intramedullary rods to the current product line, thereby offering additional design options for the surgeon. The line extension to the Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which were determined substantially equivalent via the 510(k) process. The material used to manufacture the line extension to the Long Length Gamma® Nail is identical to that of the predicate. There is no change in intended use for the line extension to the Long Length Gamma® Nail when compared to the predicate device.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) summary for a line extension of the Long Length Gamma® Nail, detailing its identification, intended use, and substantial equivalence to a predicate device. It is a regulatory document rather than a scientific study report.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information. This information is not present in the provided context for the Long Length Gamma® Nail.
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Special 510(k) Summary: Line Extension to the Long Length Gamma Nail
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677
Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:
March 7, 2002
Device Identification
| Proprietary Name: | Long Length Gamma ® Nail |
|---|---|
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |
This Special 510(k) submission is intended to address a line extension to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The line extension involves increasing the distal diameter of the nail. In addition, two shorter length Gamma® Nail Lag Screws will be added to the system. Howmedica Osteonics intends to add the new designs of intramedullary rods to the current product line, thereby offering additional design options for the surgeon. The line extension to the Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which were determined substantially equivalent via the 510(k) process. The material used to manufacture the line extension to the Long Length Gamma® Nail is identical to that of the predicate. There is no change in intended use for the line extension to the Long Length Gamma® Nail when compared to the predicate device.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
APR - 4. 2002
Re: K020773
Trade/Device Name: Long Length Gamma® Nail Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 7, 2002 Received: March 8, 2002
Dear Ms. Ariemma:
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. Karen Ariemma
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 preceded 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
lo Mark N. Mellman
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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K\u03c90773
Page 1 of 1
510(k) Number (if known): K
Device Name: Long Length Gamma® Nail System
Indications For Use:
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
f Mark N Millburn
vision of General, Restorative and Neurological Devic
510(k) Number K020773
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.