(93 days)
No
The device description details a mechanical implant system for bone fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the fixation of fractures in the proximal femur, which is a therapeutic purpose.
No
The device is a surgical implant designed for fixation of proximal femur fractures, not for diagnosing a medical condition.
No
The device description clearly lists multiple hardware components made of titanium, including a plate, hip peg, locking pin, screws, instrumentation set, and an inflation device (pump). This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of fractures in the proximal femur." This is a surgical implant used directly on the patient's bone.
- Device Description: The description details components like plates, screws, pins, and instrumentation used in surgery. These are all physical devices for internal fixation.
- 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 human body. This device is a surgical implant used to treat a physical condition within the body.
N/A
Intended Use / Indications for Use
The Fixion Dynamic Hip Screw System (Fixion DHS) is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intertrochanteric, and base of femur neck fractures. The Fixion DHS can be implanted in an open or in a minimally invasive approach.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Fixion DHS System consists of the following components: - Plate a solid, titanium-made, component, incorporating holes for the insertion of A the Hip Peg, Locking Pin and Screws. The Plate Body is shaped to comply with the hone curvature and the Barrel is located at 135° - 145° relative to the Plate Body. - Hip Peg a titanium-made tube with a distal expandable section, to enhance the A abutment of the Hip Peg inside the femoral head. The expandable body ends with a conical shaped distal end. - Locking Pin a titanium-made pin. It is used to provide additional fixation of the A fragment, if needed, and for stabilizing bone fragments in case of torsional instability - Screws titanium screws. Maximum of 3 7 Screws (Plate length dependant) can A be used to attach the plate to the bone (the femur shaft) at its distal section. - Instrumentation Set ~ a set of accessories to be used with the Fixion DHS implants. A Accessories for both open and minimally invasive surgical approaches are available. - A Inflation Device (Pump) - a manual pump used to expand the Hip Peg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, pertrochanteric, intertrochanteric, and base of femur neck
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): 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.
K010988, K012967, K023437, K983814, K964880, K972629
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.
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
510(K) Summary
Disc-O-Tech Medical Technologies Ltd. Fixion® Dynamic Hip Screw System (Fixion® DHS)
Company Name
Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya srael, 46728
Submitter's Name and Contact Person
Yael Rubin Disc-C)-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya Ísrael, 46728 Tel: + 972-9-9511511 Fax: + 972-9-9548939
Date Prepared
April 2003
Trade/Proprietary Name
Fixion® Dynamic Hip Screw System (Fixion® DHS)
Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 21 CFR 888.3030 Class II
1
'Predicate Devices
-
Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, D K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.
K031401 2/2 -
Gotfried PC.C.P (K983814) by Efratgo.
-
A Vari-Angle Hip Screw System - VHS (K964880) by Biomet.
-
ア TK2"M Compression Hip Screw System (K972629) by DePuy ACE
-
Fixion Interlocking Intramedullary Nailing System (K002873, K013449, K023437) A by Disc-O-Tech Medical Technologies, Ltd.
Performance Standards
The following standards were referred:
- A ASTM F 382 - 99: Standard Specification and Test Method for Metallic Bone Plates
-
ASTM F 384 - 00: Standard Specification and Test Method for Metallic Angled Orthopedic Fracture Fixation Devices
- A Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995
- ア The Fixion DHS implants are manufactured from Titanium and Titanium alloy, which meet the requirements of ASTM F 1472 - 02, ASTM F 136 - 02, and ASTM F 67 -- 00.
- A The Fixion DHS System accessories incorporate surgical grade Stainless Steel (complying with ASTM F 899 - 02, ASTM F 1586 - 95), Silicone and Celeron (complying with ISO 16061).
Intended Use
The Fixion Dynamic Hip Screw System (Fixion DHS) is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intertrochanteric, and base of femur neck fractures.
The Fixion DHS can be implanted in an open or in a minimally invasive approach.
2
System Description
The Fixion DHS System consists of the following components:
- Plate a solid, titanium-made, component, incorporating holes for the insertion of A the Hip Peg, Locking Pin and Screws. The Plate Body is shaped to comply with the hone curvature and the Barrel is located at 135° - 145° relative to the Plate Body.
- Hip Peg a titanium-made tube with a distal expandable section, to enhance the A abutment of the Hip Peg inside the femoral head. The expandable body ends with a conical shaped distal end.
- Locking Pin a titanium-made pin. It is used to provide additional fixation of the A fragment, if needed, and for stabilizing bone fragments in case of torsional instability
- Screws titanium screws. Maximum of 3 7 Screws (Plate length dependant) can A be used to attach the plate to the bone (the femur shaft) at its distal section.
- Instrumentation Set ~ a set of accessories to be used with the Fixion DHS implants. A Accessories for both open and minimally invasive surgical approaches are available.
- A Inflation Device (Pump) - a manual pump used to expand the Hip Peg.
Substantial Equivalence
The Fixion DHS intended use, design, matcrials, technological characteristics and principles of operation are substantially equivalent to those of Disc-O-Tech's Fixion Interlocking PF Intramedullary Nailing System (K010988, K012967, K023437) and Fixion Interlocking Intramedullary Nailing System (K002783, K013449, K023437), Gotfied PC.C.P (K983814), Biomet VHS (K964880) and DePuy ACE TK2 Compression Hip Screw System (K972629).
3
Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
AUG - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yael Rubin Director of Regulatory Affairs Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya Israel, 46728
Re: K031401 Trade/Device Name: Fixion Dynamic Hip Screw System (Fixion DHS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 7, 2003 Received: July 9, 2003
Dear Mr. Rubin:
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 such 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); good manufacturing practice requirements as set
4
Page 2 - Mr. Yael Rubin
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Disc-O-Tech Medical Technologies, Ltd. Fixion Dynamic Hip Screw System 510(k)
Indication for Use
| 510(K) Number (if known): | K031401 |
|---|---|
| --------------------------- | --------- |
Fixion® Dynamic Hip Screw System (Fixion® DHS) Device Name:
Indication for Use:
The Fixion Dynamic Hip Screw System ("Fixion DHS") is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intert:ochanteric, and base of femur neck fractures.
The Fixion DHS can be implanted in either open or minimal invasive surgical approach.
(PLEASI) DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
P : escription Use (per 21 CFR 801.109)
Over the Counter Use
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031461