(75 days)
No
The summary describes a mechanical implant (intramedullary nail) and its modifications, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is an intramedullary nail system used for fixation and temporary stabilization of various femoral fractures, indicating a therapeutic purpose.
No
The device is described as an IM (Intramedullary) Nail system used for fixation and stabilization of femoral fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a family of IM (Intramedullary) Nails, which are physical implants, not software. The submission is for a modification to the physical nail's curvature.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes an implantable medical device (an intramedullary nail) used for the fixation of bone fractures in the femur. It is surgically inserted into the patient's body.
- Intended Use: The intended use clearly states the device is for the "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". This is a therapeutic and structural function within the body, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the T2® Recon Nail System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T2® Recon Nail System 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
87 HSB
Device Description
The T2® Recon Nail System is a family of IM (Intramedullary) Nails for various types of femoral fractures. This Special 510(k) submission is intended to address modifications to the T20 Recon Nail System cleared under K032898. The anterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral neck to the supracondylar regions of the 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)
An engineering analysis of the new radius of curvature design has been performed to show that it does not affect the safety and effectiveness of the device. Potential risks analyzed include anatomical fit of the new radius of curvature as well as mechanical strength of the T2® Recon Nail. These risks have been investigated with use of failure mode effect analysis (FMEA) and prior mechanical testing which analyzed the critical loading areas of the device and demonstrate how the proposed radius of curvature does not affect device performance.
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
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
K 102992 '/2
510(k) Summary of Safety and Effectiveness: T2® RECON NAIL SYSTEM LINE EXTENSION
DEC 2 2 2010
| Proprietary Name: | T2® Recon Nail System Line Extension |
|---|---|
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 HSB: Rod, Fixation, Intramedullary And Accessories |
| For Information contact: | Avital Merl-Margulies |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6365 Fax: (201) 831-3365 | |
| Date Prepared: | December 14, 2010 |
Description:
The T2® Recon Nail System is a family of IM (Intramedullary) Nails for various types of femoral fractures. This Special 510(k) submission is intended to address modifications to the T20 Recon Nail System cleared under K032898. The anterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature.
Intended Use:
The line extension to the T2® Recon Nail System does not alter the intended use of the predicate system as cleared in its' respective premarket notification for use of the subject nail is provided below.
Indications:
The T2® Recon Nail System 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.
Proposed Modification:
The anterior to posterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature. The subject 1500mm radius of curvature nail design is substantially equivalent to
1
other devices currently marketed in the United States. A predicate device for the 1500mm radius of curvature design is the Gamma 3 Nail System cleared under K034002.
2,
Summary of Data:
An engineering analysis of the new radius of curvature design has been performed to show that it does not affect the safety and effectiveness of the device. Potential risks analyzed include anatomical fit of the new radius of curvature as well as mechanical strength of the T2® Recon Nail. These risks have been investigated with use of failure mode effect analysis (FMEA) and prior mechanical testing which analyzed the critical loading areas of the device and demonstrate how the proposed radius of curvature does not affect device performance.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430
DEC 2 2 2010
Re: K102992
Trade/Device Name: T2 Recon Nail System Line Extension Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II -Product Code: HSB Dated: October 7, 2010 Received: October 8, 2010
Dear Ms. Merl-Margulies:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 – Ms. Avital Merl-Margulies
device-related adverse events) (21 CFR 803); 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. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ais B. Nh
b.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KIO2992
Device Name: Line Extension to the T2® Recon Nail System
DEC 2 2 2010
Indications For Use:
The T2® Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neckshaft, 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.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) for M. Mellekon
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102992