(48 days)
The T2™ Femoral Nail System is a fracture fixations device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2™ Femoral Nail System is intended to provide strong and stable internal fracture 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.
The T2™ Femoral Nail is indicated for long bone fracture fixation specifically 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 proximal to a total knee arthroplasty .
- Fractures distal to hip joint ●
- Nonunions and malunions .
The T2™ Femoral Nail is a line extension to the T2™ Femoral Nail System. The T2TM Femoral Nail, in combination with the accessories from the predicate T2™ Femoral Nail Systems, is designed to treat various types of fractures of the femur.
This document describes a 510(k) premarket notification for a line extension to the T2™ Femoral Nail system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a study demonstrating performance against specific acceptance criteria. This type of submission relies on engineering analysis and comparison to existing devices. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable to this document.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numeric or qualitative acceptance criteria are provided in the document, nor is there a study detailing the device's performance against such criteria. The document states that "An engineering analysis demonstrated comparable strengths to the predicate components and is substantially equivalent to these devices." This implies that the 'acceptance criteria' are met by demonstrating equivalence to the predicate device's established performance characteristics, which are not detailed here.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Comparable strengths to the predicate components" |
| Not specified | "Substantially equivalent" to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This submission relies on an engineering analysis and comparison to a predicate device, not clinical or performance testing with a 'test set' of subjects/data in the way described for AI/diagnostic devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. See point 2.
4. Adjudication Method for the Test Set:
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a medical device (intramedullary nail) submission, not an AI or diagnostic device that would typically involve an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable in the context of clinical "ground truth" as typically used for AI/diagnostic devices. The "ground truth" in this context is the established performance and safety profile of the predicate T2™ Femoral Nail system, which the new device aims to be substantially equivalent to, as supported by an engineering analysis.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. See point 8.
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K081/52 pg 1 of 2
Summary of Safety and Effectiveness Line Extension to theT2™ Femoral Nail
JUN 1 0 2008
| Proprietary Name: | T2TM Femoral Nail |
|---|---|
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name andReference: | Intramedullary Fixation Rod andaccessories, 21 CFR §888.3020 |
| Device Product Code: | 87 HSB |
| For Information Contact: | Danielle Hillman, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365Fax: (201) 831-6038 |
| Date Summary Prepared: | April 22, 2008 |
Description:
The T2™ Femoral Nail is a line extension to the T2™ Femoral Nail System. The T2TM Femoral Nail, in combination with the accessories from the predicate T2™ Femoral Nail Systems, is designed to treat various types of fractures of the femur.
Intended Use:
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The T2™ Femoral Nail System is a fracture fixations device comprised of femoral nails and the related locking screws, compression screws, and end caps. The T2™ Femoral Nail System is intended to provide strong and stable internal fracture 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 T2™ Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures .
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- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- Fractures distal to hip joint ●
- Nonunions and malunions .
Substantial Equivalence:
The subject T2™ Femoral Nail shares the same intended use and design concepts as that of the currently available T2™ Femoral Nail System. An engineering analysis demonstrated comparable strengths to the predicate components and is substantially equivalent to these devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract eagle design, with the eagle's head facing left and its wings stylized as flowing ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2008
Howmedica Osteonics Corp. % Ms. Danielle Hillman Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
Re: K081152 Trade/Device Name: T2™ Femoral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 2, 2008 Received: June 4, 2008
Dear Ms. Hillman:
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. Danielle Hillman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biomctric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Milken
Mark N. Melkerson 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): KOSIIS A
Device Name: T2TM Femoral Nail
Indications for Use:
The T2™ Femoral Nail is indicated for long bone fracture fixation specifically 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 proximal to a total knee arthroplasty .
- . Fractures distal to hip joint
- . Nonunions and malunions
Nulke del Lvs mkm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
K081152 510(k) Number_
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)
§ 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.