(72 days)
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Not Found
No
The document describes a mechanical implant (nail system) for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
No.
The T2 Supracondylar Nail System is intended for femoral fracture fixation, acting as an aid to healing by providing strong and stable internal fixation. It is a mechanical support device, not a device that provides therapy (e.g., drug delivery, electrical stimulation, or heat therapy).
No
The device description indicates it is a surgical implant (a nail system for femoral fracture fixation), not a device used for diagnosis. Its purpose is to aid in healing by providing internal fixation, not to identify or assess medical conditions.
No
The device description clearly describes a physical implantable device (nails) made of metal, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "femoral fracture fixation" and is utilized as an "aid to healing." This describes a surgical implant used to stabilize bone fractures within the body.
- Device Description: The description details a "retrograde nail" which is a physical implant designed to be inserted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The T2 Supracondylar Nail System is an internal fixation system comprised of intramedullary nails and the related locking screws, a condyle screws, a condyle screw nut and an end cap. 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.
Indications for Use
The subject device is indicated for femoral fracture fixation, which may include the following:
- Open and closed femoral fractures .
- . Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures, including those with intra-articular extension ●
- Ipsilateral femur fractures ●
- Fractures distal to a hip joint ●
- Nonunions and malunions
- Reconstruction
Product codes
HSB
Device Description
The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar is available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
femoral
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
T2 Supracondylar Nail System
K023267
page 1 of 1 510(k) Premarket Notification
510(k) Summary for the T2 Supracondylar Nail System
Proprietary Name: Common Name: Classification Name and Reference
Regulatory Class: Device Product Code: For Information contact:
DEC 1 1 2002 T2 Supracondylar Nail System Intramedullary Nail Intramedullary Fixation Rod 21 CFR 8888.3020 Class II 87 HSB Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 831-5718 Fax: (201) 831-6038 September 26, 2002
Date Summary Prepared:
Description:
The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar is available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm.
Intended Use:
The subject T2 Supracondylar Nail System is an internal fixation system comprised of intramedullary nails and the related locking screws, a condyle screws, a condyle screw nut and an end cap. 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 Supracondylar Nail is substantially equivalent to that of the predicate device. Both the subject and predicate systems offer nails in varving lengths, and offer a combination of locking screws, condyle screws, a condyle screw nut and an end cap.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles facing to the right, with wavy lines below them. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2002
Ms. Karen Ariemma Regulatory Affairs Specialist Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401
Re: K023267
:
Trade Name: T2 Supracondylar Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 17 ,2002 Received: September 30, 2002
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
2
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 vours.
Mark McMillan
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
3
Page 1 of 1
510(k) Number (if known): Ko23267
Device Name: pracondy for Noil S
Indications For Use:
Intended Use
The T2 Supracondylar Nail System 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.
Indications for Use
The subject device is indicated for femoral fracture fixation, which may include the following:
- Open and closed femoral fractures .
- . Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures, including those with intra-articular extension ●
- Ipsilateral femur fractures ●
- Fractures distal to a hip joint ●
- Nonunions and malunions
- Reconstruction
h. Mark n. Millican
ivision Sign-Off rative Division of C. P.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
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