(78 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a plate and screw system for fracture fixation, with no mention of AI or ML.
Yes
The device is intended to treat hip fractures by stabilizing them, which is a therapeutic function.
No
The device is described as a plate and screw system intended to treat hip fractures, not to diagnose them.
No
The device description clearly states it is a "plate and screw system, made of stainless steel," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat hip fractures, which is a surgical procedure performed on a patient's body.
- Device Description: The device is a plate and screw system, which is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to treat conditions directly within the body.
N/A
Intended Use / Indications for Use
The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.
Product codes (comma separated list FDA assigned to the subject device)
87 JDO
Device Description
The GOTFRIED PC.C.P system is a plate and screw system, made of stainless steel, which utilizes dynamic femoral neck screws. The plate accepts two neck screws (length ranging from 90 mm to 140 mm) having barrel (sleeve) diameter of 9.3 mm and shaft diameter of 6.4 mm, and three 4.5 mm cortical screws (length ranging from 31 to 43 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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)
biomechanical test results, the biomechanical characteristic of the GOTFRIED PC.C.P is at least equivalent to other compression hip screw systems in terms of bending and torsional stiffness and ultimate loads to failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
bending and torsional stiffness and ultimate loads to failure.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JAN 1 4 1999
510(k) Summary
GOTFRIED PC.C.P PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES
510(k) Number K983814
Submitter's Name:
EFRATGO LTD. HI TECH BIO-SURGICAL 10 Ben Gurion St. Kyriat Bialik 27000, Israel Tel: 972-4-870-2887 Fax: 972-4-870-6610
Contact Person:
Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth St, NW Washington, DC 20004 Tel: (202) 637-5794 Fax: (202) 637-5910
Trade Name:
GOTFRIED PC.C.P (PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES)
Classification Name:
Proximal Femoral Fixation Implant Device
Classification:
The FDA has classified these devices in Class II (product code 87 JDO). Proximal femoral fixation implant devices are reviewed by the Orthopedic and Rehabilitation Devices Branch.
1
Intended Use:
The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.
Device Description:
The GOTFRIED PC.C.P system is a plate and screw system, made of stainless steel, which utilizes dynamic femoral neck screws. The plate accepts two neck screws (length ranging from 90 mm to 140 mm) having barrel (sleeve) diameter of 9.3 mm and shaft diameter of 6.4 mm, and three 4.5 mm cortical screws (length ranging from 31 to 43 mm).
Substantial Equivalence:
The GOTFRIED PC.C.P is substantially equivalent to the Synthes Proximal Femoral Nail (PFN), cleared under K970097, and the Zimmer Versa-Fx Femoral Fixation System, cleared under K954555, in terms of intended use, material and design. Moreover, based on biomechanical test results, the biomechanical characteristic of the GOTFRIED PC.C.P is at least equivalent to other compression hip screw systems in terms of bending and torsional stiffness and ultimate loads to failure.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Representing Efratgo, Limited Hi Tech Bio-Surgical 555 13th Street, NW Washington, DC 20004-1109
K983814 Re: Gotfried Percutaneous Trade Name: Compression Plating System Regulatory Class: II Product Code: JDO Dated: October 28, 1998 Received: October 28, 1998
Dear Mr. Kahan:
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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ್ಕಿ 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 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.
3
Paqe 2 - Mr. Jonathan S. Kahan
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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INDICATIONS FOR USE
510(k) Number (if known): K983814
Device Name:
GOTFRIED PC.C.P (PERCUTANEOUS COMPRESSION PLATING OF HIP FRACTURES)
Indications for Use:
The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip fractures.
(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
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983814