(101 days)
No
The description focuses on the mechanical design and materials of a femoral nail system for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Proximal Femoral Nail" intended for "fixation/stabilization of stable and unstable fractures of the proximal femur" until "bony union can occur," which directly addresses a disease condition (fractures) and is used to restore proper function.
No
Explanation: The device description clearly states its purpose is for "fixation and stabilization of fractures of the proximal femur until bony union can occur." This is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines physical components made of implant-grade titanium alloy, such as a femoral nail, lag screw, and end cap, which are surgically implanted. This 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Talon™ DistalFix™ Proximal Femoral Nail is a surgical implant used to fix and stabilize bone fractures in the proximal femur. It is a physical device implanted into the body to provide structural support.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic testing, or providing information about a patient's health through laboratory methods.
Therefore, the Talon™ DistalFix™ Proximal Femoral Nail is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Talon™ DistalFix™ Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur intertrochanteric fractures. pertrochanteric fractures. includina high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. 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™ Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts:
- . A femoral nail with a proximal portal for passage of a lag screw and distal portals that allow passage of deployable intearal 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, distal end cap and integral lock screw subassembly already installed.
- . A Talon™ lag screw with proximal portals for passage of deployable talons to increase the purchase of the lag screw within the femoral neck/head. These talons may also be retracted for removal of the lag screw if and when it is necessary. The lag screw is cannulated and keyed with tapered flats on the distal This keyed shaft allows the option of static, compression, or axial end. translation fixation types of the fracture fragments while mitigating proximal migration and rotation of the lag screw. The lag screw will be provided in a preassembled condition with the deployable talons and end cap already installed. A similar Talon™ lag screw was previously cleared in 510(k)s K014189 and K033286.
- 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 allov.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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 Data: Review of the mechanical test data indicates the Talon™ DistalFix™ Proximal Femoral Nail is substantially equivalent to the previously cleared ODi nails (K033286 and K014189).
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.
K043431, K034002, K032244, K014189, K033286
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
AUG 222 2011
SECTION 5: 510(k) SUMMARY
K111352
1 of 2
Image /page/0/Picture/3 description: The image shows a logo for ODI Orthopedic Designs North America, Inc. The logo features a stylized letter "i" inside a circle, followed by the letters "O" and "DI" in a bold, sans-serif font. Below the letters "ODI" are the words "ORTHOPEDIC DESIGNS" and "NORTH AMERICA, INC." in a smaller, sans-serif font.
Date of Preparation: May 12, 2011
Company Name / Contact:
Company:
Orthopedic Designs North America, Inc. (ODi-NA) 5912 Breckenridge Parkway Suite F Tampa, FL 33610
Contact:
Seth Masek Phone: (813) 443-4905 Fax: (888) 632-8047
Device Identification:
Proprietary Name:
Common Used Name: Classification Name:
Classification Reference: Classification Panel: Device Product Code: Proposed Regulatory Class: Talon™ DistalFix™ Proximal Femoral Nail Femoral Nail Rod, Fixation, Intramedullary and Accessories 21 CFR § 888.3020 87 - Orthopedic Devices HSB Class II
Device Description:
The Talon™ DistalFix™ Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts:
- . A femoral nail with a proximal portal for passage of a lag screw and distal portals that allow passage of deployable intearal 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, distal end cap and integral lock screw subassembly already installed.
- . A Talon™ lag screw with proximal portals for passage of deployable talons to increase the purchase of the lag screw within the femoral neck/head. These talons may also be retracted for removal of the lag screw if and when it is necessary. The lag screw is cannulated and keyed with tapered flats on the distal This keyed shaft allows the option of static, compression, or axial end.
1
KI11352 2 of Z
translation fixation types of the fracture fragments while mitigating proximal migration and rotation of the lag screw. The lag screw will be provided in a preassembled condition with the deployable talons and end cap already installed. A similar Talon™ lag screw was previously cleared in 510(k)s K014189 and K033286.
- 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 allov.
Indications for Use:
The Talon™ DistalFix™ Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur intertrochanteric fractures. pertrochanteric fractures. includina high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. 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™ Proximal 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 devices are used as predicate devices for comparison: Stryker® Gamma3™ Nail System (K043431, K034002, K032244), Orthopedic Designs (ODi) Talon™ Intramedullary Hip Nail (K014189), and Orthopedic Designs (ODi) Talon™ Long Proximal Femoral Nail System (K033286).
Mechanical Data:
Review of the mechanical test data indicates the Talon™ DistalFix™ Proximal Femoral Nail is substantially equivalent to the previously cleared ODi nails (K033286 and K014189).
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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and below the eagle are three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthopedic Designs North America, Inc. (ODi-Na) % Mr. Seth Masek 5912 Breckenridge Parkway, Suite F Tampa, Florida 33610
AUG 2 2 2011
Re: K111352
Trade/Device Name: Talon™ DistalFix™ Proximal Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 21, 2011 Received: July 22, 2011
Dear Mr. Masek:
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 (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. Seth Masek
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.
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.
Ernst Keith
Jo Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: DEVICE INDICATIONS FOR USE
510(k) Number (if known): K///352
Device Name: Talon™ DistalFix™ Proximal Femoral Nail System
Indications for Use:
Talon™ DistalFix™ Proximal Femoral Nail's primary indications are for The fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.
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)
for M. Melkerson
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111352 Page 1 of 1