(135 days)
The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:
• Diaphyseal fractures of the humeral shaft
- · Proximal humeral fractures with diaphyseal extension
- · Impending pathologic fractures
The Talon™ DistalFix™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:
- A humeral nail with proximal portals for passage of cortical locking screws ● and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
- Cortical locking screws will be provided separately. The cortical locking . screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired.
- A proximal end cap will be provided separately. The end cap prevents ● bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.
ODi-NA will manufacture the implants from implant grade titanium alloy.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "Talon™ DistalFix™ Humeral Nail."
This document primarily focuses on demonstrating substantial equivalence of the humeral nail to a predicate device based on design, materials, manufacturing, sterilization, and mechanical testing. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria, study performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.
Therefore, I cannot populate the table or answer the specific questions related to the acceptance criteria and study that proves an AI/ML device meets those criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthopedic Designs North America, Inc. Robin Wilson Quality Manager 5912 Breckenridge Parkway, Suite F Tampa, Florida 33610
February 22, 2018
Re: K173255
Trade/Device Name: Talon™ DistalFix™ Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 25, 2018 Received: January 26, 2018
Dear Ms. Wilson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
{1}------------------------------------------------
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173255
Device Name Talon™ DistalFix™ Humeral Nail
Indications for Use (Describe)
The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:
• Diaphyseal fractures of the humeral shaft
- · Proximal humeral fractures with diaphyseal extension
- · Impending pathologic fractures
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SECTION 5: 510(k) SUMMARY
Image /page/3/Picture/2 description: The image shows the logo for Orthopedic Designs North America, Inc. The logo consists of a stylized "i" inside of a circle, followed by the letters "ODI" in a bold, sans-serif font. Below the letters are the words "ORTHOPEDIC DESIGNS NORTH AMERICA, INC." in a smaller font. The logo is a dark blue color.
Date of Preparation:
January 25, 2018
Company Name / Contact:
Orthopedic Designs North America, Inc. (ODi-NA) Company: 5912 Breckenridge Parkway Suite F Tampa, FL 33610
Contact:
Robin Wilson Phone: (888) 635-8535 Fax: (888) 632-8047
Device Identification:
Talon™ DistalFix™ Humeral Nail Proprietary Name: Common Used Name: Humeral Nail Rod, Fixation, Intramedullary and Classification Name: Accessories Classification Reference: 21 CFR § 888.3020 87 - Orthopedic Devices Classification Panel: Device Product Code: нгв Proposed Regulatory Class: Class II
Device Description:
The Talon™ DistalFix™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:
- A humeral nail with proximal portals for passage of cortical locking screws ● and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
- Cortical locking screws will be provided separately. The cortical locking . screws have a reduced minor diameter at the tip which provides increased
{4}------------------------------------------------
purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired.
- A proximal end cap will be provided separately. The end cap prevents ● bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.
ODi-NA will manufacture the implants from implant grade titanium alloy.
Indications for Use:
The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including: diaphyseal fractures of the humeral shaft; proximal humeral fractures with diaphyseal extension; and impending pathologic fractures.
Substantial Equivalence Information:
Orthopedic Designs North America, Inc. believes the Talon™ DistalFix™ Humeral Nail is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. Within the proposed class, the following device is used as a predicate device for comparison: Synthes® Titanium Cannulated Humeral Nail Expert System (K033071).
Performance Data:
Review of the mechanical test data and supporting engineering analysis demonstrates the Talon™ DistalFix™ Humeral Nail System is substantially equivalent to the previously cleared Synthes® Titanium Cannulated Humeral Nail Expert System (K033071). Pyrogen testing was performed in accordance with ANSI/AAMI ST72 and confirmed the implants meet the specified endotoxin limit of 20.0 USP Endotoxin Units per device using the Limulus amebocyte lysate (LAL) test.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.