(82 days)
Not Found
No
The summary describes a mechanical implant for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to stabilize fractured bone fragments until the bone can heal and unite.
No
Explanation: The device is described as an implantable femoral nail used for fixation and stabilization of bone fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of titanium alloy, such as a femoral nail, cortical locking screws, and end caps, which are implanted into the body. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Talon™ DistalFix™ Antegrade Femoral Nail is an implantable medical device used to stabilize bone fractures within the body. It is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended use is for the fixation and stabilization of bone fractures, which is a surgical procedure, not an in vitro diagnostic test.
Therefore, based on the provided information, the Talon™ DistalFix™ Antegrade Femoral Nail is a surgical implant and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including:
- Femoral shaft fractures
- Ipsilateral femur fractures
- Supracondylar fractures, including those with intra-articular extension
- Osteoporotic fractures
- Pathologic/impending pathologic fractures
- Malunions/nonunions
The device is intended to stabilize fragments of the fracture until bony union can occur.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is used for fixation and stabilization of fractures of the femur until bony union can occur. The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail may be inserted into the femoral canal using either an antegrade or retrograde surgical approach. The system consists of the following parts:
- A femoral 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 are provided for proximal fixation if desired.
- Universal cortical locking screws will be provided separately. The universal cortical locking screws provide increased purchase in cancellous bone 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
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)
Mechanical test data indicates the subject device is substantially equivalent to the predicate device.
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
§ 888.3020 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Orthopedic Designs North America, Incorporated Robin Wilson Quality Manager 5912 Breckenridge Parkway, Suite F Tampa, Florida 33610
November 3, 2015
Re: K152295
Trade/Device Name: Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 12, 2015 Received: August 17, 2015
Dear Robin 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Robin Wilson
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
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) K152295
Device Name
Talon™ DistalFixTM Antegrade/Retrograde Femoral Nail System
Indications for Use (Describe)
The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including:
- · Femoral shaft fractures
- · Ipsilateral femur fractures
- · Supracondylar fractures, including those with intra-articular extension
- · Osteoporotic fractures
- · Pathologic/impending pathologic fractures
- · Malunions/nonunions
The device is intended to stabilize fragments of the fracture until bony union can occur.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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 larger font. Below the letters "ODI" are the words "ORTHOPEDIC DESIGNS" and "NORTH AMERICA, INC." in a smaller font.
Date of Preparation:
October 21, 2015
Company Name / Contact:
Company: Orthopedic Designs North America, Inc. (ODi-NA) 5912 Breckenridge Parkway Suite F Tampa, FL 33610
Contact:
Robin Wilson Phone: (813) 443-4905 Fax: (888) 632-8047
Device Identification:
Talon™ DistalFix™ Antegrade/Retrograde Proprietary Name: Femoral Nail Common Used Name: Femoral Nail Classification Name: Rod. Fixation, Intramedullary and Accessories Classification Reference: 21 CFR § 888.3020 Classification Panel: 87 - Orthopedic Devices Device Product Code: HSB Proposed Regulatory Class: Class II
Device Description:
The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is used for fixation and stabilization of fractures of the femur until bony union can occur. The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail may be inserted into the femoral canal using either an antegrade or retrograde surgical approach. The system consists of the following parts:
- A femoral nail with proximal portals for passage of cortical locking screws 9 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.
4
- Cortical locking screws will be provided separately. The cortical locking . screws are provided for proximal fixation if desired.
- Universal cortical locking screws will be provided separately. 0 The universal cortical locking screws provide increased purchase in cancellous bone 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 ™ Antegrade/Retrograde Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including: femoral shaft fractures; ipsilateral femur fractures; supracondylar fractures, including those with intra-articular extension: osteoporotic fractures; pathologic/impending pathologic fractures; and malunions/nonunions. The device is intended to stabilize fragments of the fracture until bony union can occur.
Substantial Equivalence Information:
Orthopedic Designs North America, Inc. believes the Talon™ DistalFix™M Antegrade/Retrograde Femoral 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: Stryker® T2 Femoral Nail System (K112059, K081152, K021744).
Mechanical Data:
Review of the mechanical test data indicates the Talon TM DistalFix TM Antegrade/Retrograde Femoral Nail is substantially equivalent to the previously cleared Stryker® T2 Femoral Nail System (K112059, K081152, K021744).