(90 days)
The T2 Arthrodesis Nail is indicated for long bone internal fixation, which may include the following:
The subject device is indicated for long bone fracture fixation, which may include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Ipsilateral femur fractures .
- Failed external fixation, nonunions and malunions .
- Periarticular fractures where repair is not possible .
- Aseptic failed total knee arthroplasty .
- Knee arthrodesis .
The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis is available in lengths from 540 mm to 780 mm increments, and in diameters from 10 mm to 15 mm.
This 510(k) summary describes a medical device, the T2 Arthrodesis Nail System, which is an intramedullary nail for internal fixation of long bones. However, the provided document does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies of AI.
The document is a 510(k) premarket notification summary and a subsequent FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than providing detailed performance study data against specific acceptance criteria.
Therefore, I cannot provide the requested table and study details. The information necessary to answer your questions is simply not present in the provided text.
The document only states the following:
- Proprietary Name: T2 Arthrodesis Nail System
- Common Name: Intramedullary Nail
- Intended Use: Internal fixation system comprised of intramedullary nails and related locking screws, compression screws, and end caps. Intended to provide strong and stable internal fixation with minimal soft tissue irritation, aiding healing.
- Indications for Use: Long bone internal fixation, including open/closed femoral fractures, pseudoarthrosis, correction osteotomy, pathologic fractures, ipsilateral femur fractures, failed external fixation, nonunions, malunions, periarticular fractures (where repair isn't possible), aseptic failed total knee arthroplasty, and knee arthrodesis.
- Substantial Equivalence: Claimed to be substantially equivalent to predicate devices in design and function. Both subject and predicate systems offer nails in varying lengths and combinations of locking screws, compression screws, and end caps.
To answer your questions, I would need a different type of document, such as a full clinical study report, a bench test report, or a detailed performance validation report, which are typically part of a more extensive submission but not always included in the public 510(k) summary.
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K02 0384 P
510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness for the T2 Arthrodesis Nail System
Proprietary Name: Common Name: Classification Name and Reference
Regulatory Class: Device Product Code: For Information contact:
T2 Arthrodesis Nail System Intramedullary Nail Intramedullary Fixation Rod 21 CFR §888.3020 Class II 87 HSB Karen Ariemma. Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 760-8187 Fax: (201) 760-8435 February 4, 2002
Date Summary Prepared:
Description:
The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis is available in lengths from 540 mm to 780 mm increments, and in diameters from 10 mm to 15 mm.
Intended Use:
The subject T2 Arthrodesis Nail System is an internal fixation system comprised of intramedullary nails and the related locking screws, compression screws and end caps. The subject device is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
Substantial Equivalence:
The design and function of the T2 Arthrodesis Nail is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer nails in varying lengths, and offer a combination of locking screws, compression screws and end caps, the combination of which varies depending on which system is used.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, wave-like appearance. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2002
Ms.Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Re: K020384
Trade/Device Name: T2 Arthrodesis Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 4, 2002 Received: February 5, 2002
Dear Ms. Ariemma:
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 (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.
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Page 2 - Ms.Karen Ariemma
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
la Mark A Millman
Celia 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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510(k) Number (if known): K O Z 84
Device Name: T2 Arthrodesis Nail System
Indications for Use
The T2 Arthrodesis Nail is indicated for long bone internal fixation, which may include the following:
The subject device is indicated for long bone fracture fixation, which may include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Ipsilateral femur fractures .
- Failed external fixation, nonunions and malunions .
- Periarticular fractures where repair is not possible .
- Aseptic failed total knee arthroplasty .
- Knee arthrodesis .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
for Mark N. Milkerer
Division Sign-Off
10n of General, Restorative d Neurological Devices
510(k) Number KD 2038
§ 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.