(321 days)
Not Found
No
The device description and intended use are purely mechanical, describing screws and wires for bone fixation. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The devices (screws and Kwires) are used for fixing bone fractures and osteotomies, which are structural repairs, not for directly treating or curing a disease or condition in a therapeutic sense.
No
Explanation: The device, the Cannulated Screw and Kirschner (Kwire) System, is described as being for "treatment and fixation of bone fractures and osteotomies." This indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly details physical components made of stainless steel (cannulated screws and Kirschner wires), indicating it is a hardware 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 the device is for the "treatment and fixation of bone fractures and osteotomies." This is a therapeutic and surgical purpose, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details surgical implants (screws and wires) made of stainless steel, designed to be placed within the body to stabilize bones. This aligns with surgical devices, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro to provide diagnostic information.
Therefore, this device falls under the category of a surgical implant for orthopedic fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
Product codes
HTN, HWC, HTY, HTV
Device Description
Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
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
The Cannulated Screw and Kirschner (K wire) System are substantially equivalent to the predicate devices with respect to design and material and dimensional comparison.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Premarket Notification
Laura Cattabriga
Cannulated Screw and Kirschner (Kwire) System
K130613
Page 1 of 2
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Smooth or threaded metallic bone fixation fastener device is provided below.
Device Common Name: Cannulated Bone Screw, Bone Fixation Fasteners
JAN 2 2 2 2014
Device Proprietary Name: Cannulated Screw and Kirschner (K wire) System
Submitter: Laura Cattabriga 7430 Center Bay Drive N. Bay Village, Florida 33141
Contact:
Laura Cattabriga 7430 Center Bay Drive North Bay Village, Florida 33141 Phone: 305-481-5588 laurac@Core-orthopaedics.com
Classification
21 CFR 888.3030 Single /multiple component metallic bone fixation Regulation: appliances and accessories
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Orthopedic Panel:
Product Code: HTN, HWC, HTY
Indication for Use: The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
Device Description: Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.
1
510(k) Premarket Notification
Laura Cattabriga
Cannulated Screw and Kirschner (Kwire) System
Page 2 of 2
Performance Data: The Cannulated Screw and Kirschner (K wire) System are substantially equivalent to the predicate devices with respect to design and material and dimensional comparison.
Substantial Equivalence:
- Internal Fixation Systems, Inc. Bone Fixation Devices (K071035) .
Internal Fixation Systems, Inc Cannulated Bone Screw (K061620) .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Ms. Laura H. Cattabriga 7430 Center Bay Drive North Bay Village, Florida 33141
Re: K130613
Trade/Device Name: Cannulated Screw and Kirschner (K wire) System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY, HTV, HTN Dated: December 17, 2013 Received: December 18, 2013
Dear Ms. Cattabriga:
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. 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 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.
3
.
- *
.
.
Page 2 - Ms. Laura H. Cattabriga
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald#AJean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification Laura Cattabriga Cannulated Screw and Kirschner (Kwire) System
-------------ﺪﺳ
Indications for Use Statement
510(k) Number (if known): K130613
Device Name: Cannulated Screw and Kirschner (Kwire) System
Indications For Use:
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, tarsals, metatarsals and fibula
x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Elizabeth L. Frank -S
Page 1 of
Division of Orthopedic Devices