(84 days)
Not Found
No
The description focuses on the mechanical components and intended use of a surgical implant, with no mention of AI or ML.
No
This device is an intramedullary nail used to treat fractures, which is a structural implant and not a device that provides therapy.
No
The device is an intramedullary nail system (Synthes modified PFN System) intended for the treatment of proximal femoral fractures, not for diagnosing them.
No
The device description clearly outlines physical components made of titanium alloy, such as intramedullary nails, screws, and pins, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Synthes modified PFN is a "cannulated intramedullary nail" and lists components like nails, screws, and bolts. These are all physical implants used to treat bone fractures.
- Intended Use: The intended use is to "treat stable and unstable proximal femoral fractures." This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used for orthopedic treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Synthes modified PFN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal non-unions and malunions and revision procedures.
Product codes
HTY
Device Description
Synthes modified PFN System is a cannulated intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. The following components make up the PFN system: proximal femoral nails, hip pins, femoral neck screws, locking bolts, and end caps. Synthes modified PFNs are available in lengths of 240 mm (short) and 340, 380, and 420 mm (long). The nails allow for both proximal and distal locking options. Synthes modified PFN System is manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femoral, trochanteric and diaphyseal areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A small registered trademark symbol is located to the right of the letter "S" in "SYNTHES".
Attachment VIII:
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) SUBMITTER NOV 20 1997 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Sheri L. Musgnung COMMON OR USUAL Nail, Fixation, Bone Pin. Fixation. Threaded NAME: Class II, 21 CFR 888.3020; 888.3040 DEVICE CLASSIFICATION: Synthes Proximal Femoral Nail (K970097) PREDICATE DEVICE: Synthes modified PFN System is a cannulated intramedullary nail DESCRIPTION: which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. The following components make up the PFN system: proximal femoral nails, hip pins, femoral neck screws, locking bolts, and end caps. Synthes modified PFNs are available in lengths of 240 mm (short) and 340, 380, and 420 mm (long). The nails allow for both proximal and distal locking options. Synthes modified PFN System is manufactured from titanium alloy. The Synthes modified PFN is intended to treat stable and INTENDED USE: unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal nonunions and malunions and revision procedures.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 19301 Paoli, Pennsylvania
NOV 20 1997
Re: K973240 Synthes (USA) Proximal Femoral Nail System Modifications Regulatory Class: II Product Code: HTY Dated: Auqust 27, 1997 Received: August 28, 1997
Dear Ms. Musgnung:
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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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 - Ms. Sheri L. Musgnung
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 i may in i 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,
Cole M. Whitten, Ph.D.
Cella 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/3/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, black, sans-serif font. The symbol appears to be a stylized representation of a person or figure within a circle. A registered trademark symbol is located to the right of the word "SYNTHES".
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli. Pennsylvania 19301 Telephone 610-647-9700
Page _ of
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Synthes modified PFN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal non-unions and malunions and revision procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
P. Colles
(Division Sign-Off) Division of General Restorative Devices 510(k) Number .
Original Instruments and Implants of the Association for the Study of Internal Fixation--AO/ASIF