(183 days)
No
The description focuses on mechanical components and performance testing, with no mention of AI or ML.
No
This device is for fixation of fractures, which is a supportive and structural purpose, not a therapeutic treatment of disease or condition.
No
Explanation: The device is intended for fixation of fractures to the proximal femur, which is a therapeutic rather than a diagnostic purpose. The description focuses on its components and mechanical properties for surgical implantation, with no mention of diagnostic functions like imaging, analysis of medical data, or identification of diseases.
No
The device description explicitly lists physical components like plates, screws, and blades, indicating it is a hardware-based medical device for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures to the proximal femur." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components (plates, screws, blades) are all physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform any such analysis of specimens.
This device is a surgical implant used to treat bone fractures.
N/A
Intended Use / Indications for Use
The ODRC-Dynamic Hip Screw System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or Intertrochanteric zones.
Product codes
KTT, HRS, HWC
Device Description
The ODRC-Dynamic Hip Screw System consists of non-sterile ODRC-DHS Plate, ODRC-DHS Screw, ODRC-DHS Blades, compression screw, and 4.5 mm cortex screw. The ODRC-DHS Plate is a straight with an angled barrel portion that accepts ODRC-DHS Screw and ODRC-DHS Blades. The barrel angle is 135° and length of 36 mm. The plates are available in multiple lengths (lengths ranging from 46 mm to 206 mm) to accommodate differing patient anatomy. The plate accepts DHS Helix Screw (lengths ranging from 75 mm to 130 mm) and 4.5 mm cortex screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, such as femoral neck, trochanteric, pertrochanteric, or Intertrochanteric zones.
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
Mechanical testing (static and dynamic four point bending test (ASTM F382), and static and dynamic axial compression bending test (ASTM F384)) was conducted to demonstrate substantial equivalence to the predicate system. The results demonstrate that the ODRC-Dynamic Hip Screw System performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
SYNTHES DHS System (K981757)
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
K1030156pg 1/2)
Chapter 1 510(k)Summary
APR 1 3 2011
510(K) SUMMARY
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92.
| Sponsor : | ORTHOPAEDIC DEVICE RESEARCH CENTER
No. 155. Sec. 2 Li-Nung St.
Orthopaedic Device Research Center
National Yang-Ming University
Taipei 11221
Taiwan
Phone:886-2-28267020
Fax:886-2-28228557 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cheng-Kung Cheng
Direct, Orthopaedic Device Research Center |
| Device Name: | ODRC-Dynamic Hip Screw System |
| Classification: | Class II : Plate, Fixation, Bone
HRS-CFR 888.3030 Class II : Screw, Fixation, Bone
HWC — CFR 888.3040 Class II : Appliance, fixation, nail/blade/plate
combination, multiple component
KTT — CFR 888.3030 |
| Predicate Devices : | SYNTHES DHS System (K981757) |
Material :
The ODRC-Dynamic Hip Screw System components are manufactured from medical grade 316L stainless steel that meets ASTM F138 & ASTM F139/lSO 5832-1.
1
Device Description :
The ODRC-Dynamic Hip Screw System consists of non-sterile ODRC-DHS Plate, ODRC-DHS Screw, ODRC-DHS Blades, compression screw, and 4.5 mm cortex screw. The ODRC-DHS Plate is a straight with an angled barrel portion that accepts ODRC-DHS Screw and ODRC-DHS Blades. The barrel angle is 135° and length of 36 mm. The plates are available in multiple lengths (lengths ranging from 46 mm to 206 mm) to accommodate differing patient anatomy. The plate accepts DHS Helix Screw (lengths ranging from 75 mm to 130 mm) and 4.5 mm cortex screws.
Indication for Use :
The ODRC-Dynamic Hip Screw System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or Intertrochanteric zones.
Performance Data :
Mechanical testing (static and dynamic four point bending test (ASTM F382), and static and dynamic axial compression bending test (ASTM F384)) was conducted to demonstrate substantial equivalence to the predicate system. The results demonstrate that the ODRC-Dynamic Hip Screw System performs as well as or better than the predicate device.
Basis of Substantial Equivalence :
The ODRC-Dynamic Hip Screw System has been demonstrated to be substantially equivalent to predicate system with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a specific department or division within the FDA.
Orthopaedic Device Research Center % Cheng-Kung Cheng No. 155, Sec 2. Li-Nung Street Taipei China (Taiwan) 112
APR 1 3 2011
Re: K103015
Trade/Device Name: ODRC -- Dynamic Hip Screw System Regulation Number: 888.3040 Regulation Name: Regulatory Class: Class II Product Code: KTT, HRS, HWC Dated: March 31, 2011 Received: April 8, 2011
Dear Mr.Cheng:
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 iddictions 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 Foond, Or ug 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
3
Page 2 - Mr. Cheng - Kung Cheng
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Alig B. rita
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
Indications for Use
510(k) Number (K103015):
Device Name: ODRC-DHS System
Indications for Use:
The ODRC-DHS System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M.Meukerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
4-4