(22 days)
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No
The summary describes a mechanical fracture fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a fracture fixation device intended to aid in the healing of various femoral fractures, making it a therapeutic device.
No
The device is described as a "fracture fixation device" and its intended use is to aid in the healing of femoral fractures by providing "strong and stable internal fracture fixation." There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states it is comprised of physical components like femoral nails, washers, screws, and end caps, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation of bone fractures within the body (femur and tibia). This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "fracture fixation device comprised of femoral nails and the related accessories." This further confirms its role as an implant for stabilizing bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
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 subject T2 Recon Nail System is a fracture fixation device comprised of femoral nails and the related accessories such as washers, locking screws, end caps, and lag screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The T2 Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Product codes
HSB
Device Description
The subject T2 Recon Nail System is a fracture fixation device comprised of femoral nails and the related accessories such as washers, locking screws, end caps, and lag screws. The subject and predicate devices are made from Titanium alloy. This Special 510(k) submission is intended to address design changes to the Alta CFx Reconstruction Rod System and the T2 Nail System. The major design changes involve a modification to the proximal end of the nail, and the inclusion of additional lengths and diameters plus new accessories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tibia, Femur, femoral neck, supracondylar regions of the femur
Indicated Patient Age Range
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Intended User / Care Setting
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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)
FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Recon Nail System to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
0
OCT - 9 2003
Special 510(k) Summary: T2 RECON Tibial Nail System
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Howmedica Osteonics Corp 59 Route 17 Allendale. NJ 07401-1677
Contact Person:
Vivian Kelly Regulatory Affairs Consultant
Date of Summary Preparation:
September 16, 2003
Device Identification
T2 Recon Nail System Proprietary Name: Intramedullary Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod 21 CFR 8888.3020
This Special 510(k) submission is intended to address design changes to the Alta CFx Reconstruction Rod System and the T2 Nail System. The major design changes involve a modification to the proximal end of the nail, and the inclusion of additional lengths and diameters plus new accessories. There is no change in intended use for the modified device when compared to the previously cleared device.
Intended Use
The subject T2 Recon Nail System is a fracture fixation device comprised of femoral nails and the related accessories such as washers, locking screws, end caps, and lag screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
Statement of Technological Comparison:
The subject and predicate devices are made from Titanium alloy. FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Recon Nail System to the predicate devices.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K032898
Trade/Device Name: T2 Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 16, 2003 Received: September 17, 2003
Dear Ms. Kelly:
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. Vivian Kelly
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 (301) 594-4659. 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 vours.
Mark n 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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Page 1 of 1
510(k) Number (if known): K
Device Name: T2 Recon Nail System
Indications For Use:
The T2 Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Mark N. Milkersson
vision Sign-Off) Division of General. Restorative and Neurological Devices 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)