(19 days)
Not Found
No
The document describes a mechanical implant (intramedullary nail) and its intended use and materials. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device is used to treat various conditions such as degeneration, deformity, trauma, and rheumatoid arthritis within the hindfoot, which aligns with the definition of a therapeutic device designed to alleviate or cure medical conditions.
No
The device is described as an "intramedullary nail used for fixation," which indicates it is a therapeutic or reconstructive device, not a diagnostic one. Its intended use is for conditions requiring arthrodesis (fusion), not for identifying or assessing medical conditions.
No
The device description clearly states it is an intramedullary nail made from titanium alloy, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant used for fixation of bones in the ankle and hindfoot to treat various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is an intramedullary nail made of titanium alloy, which is a material used for surgical implants.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TriGen Hindfoot Fusion Nail (HFN) is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints. The TriGen HFN is for single use only.
Product codes
HSB
Device Description
The TriGen Hindfoot Fusion Nail (HFN) is an intramedullary nail used for fixation of the ankle and hind foot. The TriGen HFN nails are made from titanium alloy conforming to ASTM F 1472 and are used with existing bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle and hind foot; tibiotalar and talocalcaneal articulations
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A review of the mechanical test data indicated that the TriGen HFN is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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NOV 2 4 2004
Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Hindfoot Fusion Nail
Date of Summary: November 4, 2004
Contact Person and Address
Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 1901) 399-5153
Name of Device: TriGen Hindfoot Fusion Nail Common Name: Intramedullary Fixation Rod
Device Description
The TriGen Hindfoot Fusion Nail (HFN) is an intramedullary nail used for fixation of the ankle and hind foot. The TriGen HFN nails are made from titanium alloy conforming to ASTM F 1472 and are used with existing bone screws.
Device Classification
21 CFR 888.3020 Intramedullary fixation rod - Class II
Mechanical and Clinical Data
A review of the mechanical test data indicated that the TriGen HFN is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Indications for Use
The TriGen Hindfoot Fusion Nail (HFN) is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints. The TriGen HFN is for single use only.
Substantial Equivalence Information
The substantial equivalence of the TriGen HFN is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - the Smith & Nephew, Inc. Tibia-Talus-Calcaneus Nail (K950394) and the Encore Orthopedics UltiMax Ankle Fusion Rod System (K991790).
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K043052
Trade/Device Name: TriGen Hindfoot Fusion Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: October 4, 2004 Received: October 5, 2004
Dear Ms. Akil:
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 such 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); 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.
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Page 2 - Ms. Janet Johnson Akil
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: TriGen Hindfoot Fusion Nail
Indications for Use:
The TriGen Hindfoot Fusion Nail (HFN) is indicated for degeneration, deformity, or rauma of both The Tricen Hindbot rusion Nak (11), is marbated for asso ;
the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodest combined the tiblotalial and sub-talarons in the hillering in the nike and sub-talar joints;
arthrodesis of the ankle and sub-talar joints; avascular necrosis of the anily incriff ris annrodesis of the ankle and sub-talar intrusion; failed ankle arthrodesis with insufficient lalled lotal anke replacentern with secondary to untreated talipes equinovarus or lalar body; medihatolu annitis; corors aufemily so the subtalar joints. The TriGen HFN is for single use only.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use (21 CFR 807 Subpart C) | |
|---|---|
| --------------------------------------------- | -- |
(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Confurrence of CORH,
510(k) Number K043052
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