(65 days)
The intended use of the Gamma3® Nail System includes the following:
Trochanteric Gamma3® Nail: The Trochanteric Gamma3® Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.
Long Length Gamma3® Nail: The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.
The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.
The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and femoral shaft fractures and consists of nails, lag screws, locking screws and set screws. The subject device is a line extension to the Gamma3 Nail System previously cleared in 510(k)s K034002 and K032244 to provide additional components and accessories to the system.
This 510(k) Premarket Notification describes a line extension to an existing intramedullary nail system (Gamma3 Nail System). It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a regulatory submission for a medical device and focuses on establishing substantial equivalence to previously cleared predicate devices. Substantial equivalence claims are based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than on new performance studies with specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document. The document primarily serves to inform the FDA that the new components (line extension) are within the scope and safety profile of the already approved Gamma3 Nail System.
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FEB 1 6 2005
K 043431
Traditional 510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness: Line Extension to the Gamma3 Nail System
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact:
Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430
Jennifer Kosoy, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: (201) 831-5601 Fax: (201) 831-6038 Email: jennifer.kosoy@stryker.com
Date Summary Prepared
December 9, 2004
Device Identification
Proprietary Name: Common Name: Classification Name and Reference:
Device Product Code: Predicate Device:
Gamma3® Nail System Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR 8888.3020 87 HSB Gamma3 Nail System, K034002 and K032244
Description
The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and femoral shaft fractures and consists of nails, lag screws, locking screws and set screws. The subject device is a line extension to the Gamma3 Nail System previously cleared in 510(k)s K034002 and K032244 to provide additional components and accessories to the system.
Intended Use
The intended use of the Gamma3 Nail System includes the following:
Trochanteric Gamma30 Nail
The Trochanteric Gamma3® Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.
Long Length Gamma30 Nail
The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.
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Indications for Use
The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3 Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2005
Ms. Jennifer Kosoy Regulatory Affairs Specialist Howmedica Osteonics Corp 325 Corporate Drive Mahwah, New Jersey 07430
Re: K043431
Ro45451
Trade/Device Name: Line Extension to the Gamma® 3 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: December 10, 2004 Received: December 13, 2004
Dear Ms. Kosoy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications felerenced above and nave determined the articled predicate devices marketed in interstate for use stated in the enorosale) to regard) the enactment date of the Medical Device American Council Food. Drus commerce prior to May 28, 1776, the enated with the provisions of the Federal Food. Drug, devices mat have been recultsmed in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of gencial controls provisions of the rest 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 ( If your device is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation Fif may be subject to such additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peace concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a badenian.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determination an Journistered by other Federal agencies. You must of any rederal statutes and regulations animations but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setsen CFK Fart 807), adocing (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Jennifer Kosoy
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,
Mark A. Millerson
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):
Device Name: Line Extension to the Gamma®3 Nail System
and the comments of the comments of the comments of the comments of the comments of
Indications For Use:
The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, turnor resections and revision procedures.
The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
AND/OR
Over-The-Counter Use __
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_
§ 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.