(85 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical implant system for fracture fixation, with no mention of software, algorithms, or any technology related to AI or ML.
No
This device is a surgical implant designed to provide mechanical support and stabilization for bone fractures, aiding in the natural healing process. It does not actively treat or cure a disease or condition in the way a therapeutic device typically would (e.g., drug delivery, energy delivery, or direct physiological modification).
No
Explanation: The device is described as an implantable system (Dynamic Hip Screw System) used in the treatment of femoral neck fractures, providing support during bone regeneration. Its purpose is therapeutic (fixation and support), not diagnostic (identifying or characterizing a condition).
No
The device description explicitly states it comprises physical components made of stainless steel (Dynamic Compression Plates and Compression Lag Screws) and is implanted using instruments. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 Dynamic Hip Screw System devices are implantable devices used to provide mechanical support to the femur and femoral head during bone healing. They are designed to withstand in vivo loads.
- Intended Use: The intended use is to treat femoral neck fractures by providing structural support, not by analyzing biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Dynamic Hip Screw System devices are used in the treatment of femoral neck fractures in the pertrochanteric, intertrochanteric and high subtrochanteric regions of the femur, or in the treatment of combinations of these fractures.
Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric High subtrochanteric fractures occur fractures occur within the trochanteric area. immediately below the trochanter.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral fracture.
The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
Product codes
COKTT
Device Description
The Dynamic Hip Screw System comprises stainless steel Dynamic Device Description: Compression Plates and Compression Lag Screws and optional Hexagonal Screw for use in the fixation of femoral neck fractures.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral neck fracture. The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
A dedicated Corifix Dynamic Hip Screw instrument set is used to implant the devices or Stratetc (Synthes) instruments may be used.
Each of the implantable devices is manufactured form stainless steel which in certified to BS 7252 Part 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
femoral neck, femur, femoral head
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) SUMMARY
| Name of Company: | Corifix Ltd
The Corinium Centre
Cirencester
Gloucestershire
GL7 1YJ
England |
|------------------|--------------------------------------------------------------------------------------------|
| Name of Device: | Corifix Dynamic Hip Screw System |
The Dynamic Hip Screw System comprises stainless steel Dynamic Device Description: Compression Plates and Compression Lag Screws and optional Hexagonal Screw for use in the fixation of femoral neck fractures.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral neck fracture. The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
A dedicated Corifix Dynamic Hip Screw instrument set is used to implant the devices or Stratetc (Synthes) instruments may be used.
Each of the implantable devices is manufactured form stainless steel which in certified to BS 7252 Part 1.
SUBSTANTIAL EQUIVALENCE AND SAFETY AND SUMMARY OF EFFECTIVENESS
The Corifix Dynamic Hip Screw System is substantially equivalent to the Stratec (Synthes) DHS System for the following reasons:
- Both are manufactured from 316 LVM stainless steel. a)
- Both have a similar range of plate angles and holes. b)
- c) Both are designed to be used to treat proximal hip fractures.
- Both of the plates are the same thickness and width. d)
- Both have the same outside barrel diameter. e)
This type of device has been in clinical use for over twenty years and no significant problems have been reported.
The Corifix Hip Screw has been in clinical use outside the USA for three years and no postoperative problems have been reported.
The Corifix product design is generic and equivalent to the Synthes DHS System.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird, with three human profiles incorporated into its design. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Mr. Craig Corrance President Corin U.S.A. 10500 University Center Drive Suite 130 Tampa, Florida 33612
K973231 Re: Corifix Dynamic Hip Screw Trade Name: Regulatory Class: II Product Code: COKTT Land: Comm Dated: August 12, 1997 Received: August 27, 1997
Dear Mr. Corrance:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ਖੇ 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory 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 - Mr. Craig Corrance
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,
G. Celia M. Whitton, Ph.D., M.
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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510(k) Number (if known):
The Corifix Dynamic Hip Screw System Device Name:
INDICATIONS FOR USE
The Dynamic Hip Screw System devices are used in the treatment of femoral neck fractures in the pertrochanteric, intertrochanteric and high subtrochanteric regions of the femur, or in the treatment of combinations of these fractures.
Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric High subtrochanteric fractures occur fractures occur within the trochanteric area. immediately below the trochanter.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral fracture.
The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
signature
(Division Sign-Off) Division of General Restorative Devices
510(k) Number K973231
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use