(87 days)
Not Found
No
The device description and intended use focus solely on the mechanical properties and surgical application of cannulated screws, with no mention of AI or ML.
No.
The device is described as a system of screws for fixation of bones, osteotomies, and arthrodesis, which are surgical procedures for structural support rather than a therapy to treat a disease or condition.
No
The provided text describes a medical device, the Ascension Cannulated Screw System, which is used for the fixation of fractures, arthrodesis, and osteotomies. These are surgical procedures for treatment, not diagnostic processes. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states it consists of metallic screws, washers, guide wires, and surgical instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Ascension Cannulated Screw System: This device is a surgical implant used to fix bones within the body. It is a physical device used in a surgical procedure, not a test performed on a sample.
The description clearly outlines its use in surgical procedures for bone fixation and arthrodesis, which are not diagnostic activities.
N/A
Intended Use / Indications for Use
The Ascension Cannulated Screw System is intended for the following:
- Fixation of fractures in long bones
- Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow .
- Arthrodesis of the foot, wrist and elbow
- A Small and long bone osteotomies
Product codes
HWC
Device Description
The Ascension® Cannulated Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannabulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel or titanium. Washers, as well as guide wires, and various orthopedic surgical instruments will be included in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, foot, patella, ankle, wrist, elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
K991151, K991197, K962823, K893512, K901616
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
K092yyo
510(k) Summary
NOV - 5 2009
SUBMITTER NAME: Ascension Orthopedics, Inc. 8700 Cameron Road, #100 Austin, TX 78754-3832
- 510(k) CONTACT: Debbie Stearns Phone: (512) 836-5001 x1548
Ascension® Cannulated Screw System TRADE NAME:
COMMON NAME: Cancellous Cannulated Bone Screws
CLASSIFICATION: 21 CFR 888.3040 - Bone Fixation Screw
PRODUCT CODE: HWC
- Orthopedic PANEL:
PREDICATE DEVICES:
K991151 and K991197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith & Nephew Cannulated Interference Screw System
DEVICE DESCRIPTION:
The Ascension® Cannulated Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel or titanium. Washers, as well as guide wires, and various orthopedic surgical instruments will be included in the system.
INTENDED USE:
The Ascension Cannulated Screw System is intended for the following:
-
Fixation of fractures in long bones
-
Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow .
-
Arthrodesis of the foot, wrist and elbow
- A Small and long bone osteotomies
BASIS OF SUBSTANTIAL EQUIVALENCE:
Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials and indications.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV - 5 2009
Ascension Orthopedics, Inc.
% Ms. Debbie Stearns Director, Regulatory/Clinical Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832
Re: K092440
Trade/Device Name: Ascension® Cannulated Screw System Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 5, 2009 Received: October 5, 2009
Dear Ms. Stearns:
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 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
2
Page 2 - Ms. Debbie Stearns
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.
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/ReportalProblem/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,
Mark A. Williamson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
KB92440 510(K) Number.
Device Name:
Ascension® Cannulated Screw System
Indications for Use:
The Ascension Cannulated Screw System is intended for the following:
- Fixation of fractures in long bones a
- Fixation of small bones, including those in the foot, patella, ankle, wrist and A elbow
- Arthrodesis of the foot, wrist and elbow A
- Small and long bone osteotomies A
Prescription Use × OR
Over-The-Counter Use
(Part 21 CFR 801Subpart B) C)
(Part 21 CFR 801Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Souther for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092440
K092440 - Ascension Cannulated Screw System