(315 days)
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Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used for the treatment of fractures and osteotomies, which are medical conditions, making it a therapeutic device.
No
The device is a surgical implant designed for the treatment of fractures and osteotomies, not for diagnosing conditions. Its description focuses on fixation and treatment, not on identifying diseases or conditions.
No
The device description clearly states it consists of physical components like adjustable plates, lag screws, compression screws, and bone screws, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for fixing bone fractures in the hip. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like plates, screws, and a fixation system, which are typical of orthopedic implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Vari-Angle Hip Screw System is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.
Product codes
KTT
Device Description
The Vari-Angle Hip Screw System is a compression hip fixation system used for the treatment of femoral neck fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
Materials: The devices are manufactured from 316 LVM stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the femoral neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (femoral neck, sub-capital, sub-trochanteric, inter-trochanteric, femoral capital epiphysis)
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
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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)
Free-Lock Compression Hip Fixation System ( Zimmer ), AMBI Hip Screw System ( Richards ), Dynamic Hip Screw ( DHS ) ( Synthes ), Versa-Fx Femoral Fixation System ( Zimmer ), Ace Captured Hip Screw System ( Ace Medical ), Combination NoLok/ Keyed Compression Hip Screw System ( DePuy ) t, Medoff Sliding Plate ( Wright Medical Technology )
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.
0
OCT 16 1007
Summary of Safety and Effectiveness for
Vari-Angle Hip Screw System
This safety and effectiveness summary for the Vari-Angle Hip Screw ( VHS ) System is provided as required per Section 513(x) (1) (1) (1) (1) Food, Drug and Cosmetic Act. !
Contact Person : 1. Submitter : Walter Abendschein, M.D. Walter Abendschein, M.D. 5530 Wisconsin Avenue, Suite 705 5530 Wisconsin Avenue, Suite 705 Chevy Chase, Md. 20815 Chevy Chase, Md. 20815 Telephone: (301) 656-4317
Date Prepared: November 27,1996
| 2. Tradename: | Vari-Angle Hip Screw ( VHS ) System |
|---|---|
| Common Name: | Compression Hip Screw System |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories |
| (888.3030) |
3. Predicate or legally marketed devices which are substantially equivalent:
- Free-Lock Compression Hip Fixation System ( Zimmer ) ●
- AMBI Hip Screw System ( Richards ) ●
- Dynamic Hip Screw ( DHS ) ( Synthes ) .
- Versa-Fx Femoral Fixation System ( Zimmer ) .
- Ace Captured Hip Screw System ( Ace Medical ) ●
- Combination NoLok/ Keyed Compression Hip Screw System ( DePuy ) t
- Medoff Sliding Plate ( Wright Medical Technology ) .
4. Description of the device :
The Vari-Angle Hip Screw System is a compression hip fixation system used for the treatment of femoral neck fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
Materials: The devices are manufactured from 316 LVM stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the femoral neck.
5. Intended Use:
The Vari-Angle Hip Screw System is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.
-
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Vari-Angle Hip Screw System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 1997
Walter Abendschein, M.D. 5530 Wisconsin Avenue Suite 705 20815 Chevy Chase, Maryland
K964880 Re: Vari-Angle Hip Screw (VHS) System Trade Name: Regulatory Class: II Product Code: KTT Dated: July 21, 1997 Received: July 21, 1997
Dear Dr. Abendschein:
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 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. 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 regulation 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.
2
Page 2 - Walter Abendschein, M.D.
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 requlation (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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Page 1 of 1
510(k) Number ( if known ) : K964880
Device Name : Vari-Angle Hip Screw System
Indications For Use :
The Vari-Angle Hip Screw is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ) 【イロログコン】
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Prescription use
( PER 21 CFR 801.109)
OR
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
( optional format 1-2-96 )
Acolly
eneral Restorative D