(134 days)
Not Found
No
The 510(k) summary describes a passive, physical implant (a nitinol staple) used for bone fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The device's function is purely mechanical.
No.
The device is an implant for bone fixation and joint fusion, not a therapeutic device designed to treat or alleviate a disease or condition through non-surgical means. It is a surgical implant.
No.
The device is described as an implant for fixation and arthrodesis of bones and joints, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted," which is a physical hardware implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Metasurg Nitinol Staple implant is a permanently implanted bone fixation device. It is used within the body to fix bones and joints.
- Intended Use: The intended use is for "fixation and arthrodesis of the associated bones and joints of the hands and feet." This is a surgical procedure performed on the body, not a laboratory test on a specimen.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet.
The Metasurg Nitinol Staple implants are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Metasurg Nitinol Staple Implant is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands and feet
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)
A design, dimensional comparison and standardized tests were performed to establish substantial equivalence in terms of intended use and indications for use, material, design and function to the legally marketed predicate devices listed in this summary.
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.
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.
Not Found
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
MAY -3 2013
Date Prepared:
Sponsor:
December 19, 2012
Metasurg 15115 Park Row, Suite 100 Houston, TX 77084
Company Contact:
Joshua Scott Phone: (281) 398-5656 Fax: (281) 398-5660
Bone Staple
Metasurg Nitinol Staple Implant
Device Trade Name:
Classification Name:
Single/Multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030, Product Code JDR, Class II)
Common Name:
Predicate Devices:
Device Description:
Intended Usage:
Material:
Memometal Memory Staples (K070031) Biomedical Enterprises, Inc. Memograph Staple (K993714)
The Metasurg Nitinol Staple Implant is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.
The Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet.
The Metasurg Nitinol Staple implants are intended for single use only.
Nickel Titanium Alloy (Nitinol) per ASTM F2063-05
Technological Characteristics: The Metasurg Nitinol Staple implant and the other legally marketed predicate devices listed in this summary have similar indications, physical dimensions and are constructed of nickel titanium alloy (Nitinol).
1
K123926 (2/2)
Substantial Equivalence:
A design, dimensional comparison and standardized tests were performed to establish substantial equivalence in terms of intended use and indications for use, material, design and function to the legally marketed predicate devices listed in this summary.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Metasurg % Mr. Joshua Scott Vice President of Engineering 15115 Park Row, Suite 100 Houston, Texas 77084
Re: K123926
Trade/Device Name: Metasurg Nitinol Staple Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: April 19, 2013 Received: April 22, 2013
Dear Mr. Scott:
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
3
Page 2 - Mr. Joshua Scott
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 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/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: Pending --- K123926
Device Name: Metasurg Nitinol Staple Implant
Indications for Use:
The Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet.
The Metasurg Nitinol Staple implants are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices