(156 days)
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.
The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and up to two distal locking bolts.
This 510(k) summary (K083648) describes a medical device, "The Gotfried PH (Physiological Hip) Nail," which is an intramedullary nail for hip fracture fixation. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include information on software performance.
The document is a standard 510(k) summary for a Class II medical device (Intramedullary fixation rod). It primarily focuses on:
- Identification of the device and its submitter.
- Classification of the device and its predicate devices.
- Description of the device: An intramedullary nail with two proximal dynamic femoral neck screws and up to two distal locking bolts, made of stainless steel.
- Intended Use: Fractured bone stabilization, fixation, and management of specific types of proximal femur fractures (trochanteric, subtrochanteric, subcapital, and base of neck).
- Comparison to predicate devices: States that it is "substantially equivalent" in technology, construction, materials, and orthopedic design principles. It explicitly mentions its dimensions and tolerances are within the range of previously cleared devices.
Therefore, I cannot provide the requested table and information about acceptance criteria and study details because the provided text does not contain this information. This type of information (performance studies, acceptance criteria for software, sample sizes, ground truth) is typically found in the more detailed sections of a 510(k) submission, not usually in the publicly available 510(k) summary document itself, especially for a hardware device like an intramedullary nail. The substantial equivalence argument for this device relies on its similarity to existing, legally marketed predicate devices, rather than on new performance studies with specific acceptance criteria that would be relevant for software or AI.
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510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
MAY 14 2009
- Submitter Efratgo Ltd. Hi Tech Bio-Surgical 1. Address: 49 Derech Acco Ave. Kiryat Motzkin Israel 26736
Phone: 972-4-870-6628
Contact
Person: Yechiel Gotfried, MD
Date: December 4, 2008
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- Device & Gotfried PH (Physiological Hip) Nail Classification Device: Rod, Fixation, Intramedullary, and Accessories Name:
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- Description: The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and up to two distal locking bolts.
- The Gotfried PH (Physiological Hip) Nail is intended for 5. Intended Use: fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric). subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.
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- In terms of technology, the Gotfried PH (Physiological Hip) Nail Comparison of is substantially equivalent to its predicate devices. It is Technological Characteristics: constructed of stainless steel and incorporates the same orthopedic design principles and components as its predicate devices. Its dimensions and the majority of tolerances are within the range that has been previously determined to be substantially equivalent by the FDA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 with three stylized wing segments.
Public Health Service
MAY 14 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Efratgo Ltd. Hi Tech Bio-Surgical % MedicSense Mr. George J. Hattub Senior Staff Consultant 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K083648
Trade/Device Name: The Gotfried PH (Physiological Hip) Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 28, 2009 Received: May 1, 2009
Dear Mr. Hattub:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. George J. Hattub
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: The Gotfried PH (Physiological Hip) Nail
Indications For Use: The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonetu
(Division Sign Off)
(DWision Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083648
§ 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.