(20 days)
Not Found
No
The summary describes a mechanical fixation device and its intended use, without any mention of AI or ML capabilities.
Yes
The device is described as a "fixation device" intended to provide "strong and stable fixation" for "long bone fracture fixation," which is a therapeutic purpose.
No
Explanation: The T2 Femoral Nail System is a fixation device used for long bone fracture fixation, not for diagnosing conditions. Its purpose is mechanical support and stabilization.
No
The device description clearly states it is a physical implant (a titanium alloy tube) and related hardware (screws, end caps), 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 T2 Femoral Nail System is a "fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps." It is used to "provide strong and stable fixation" for bone fractures. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The T2 Femoral Nail System does not perform any such tests on bodily samples.
- Device Description: The description details a physical implantable device (a metal nail and screws) designed for surgical insertion into the femur.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples
- Detecting or measuring substances in samples
- Providing diagnostic information based on laboratory tests
Therefore, the T2 Femoral Nail System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The T2 Femoral Nail System is a fixation 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 meeting 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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The T2 Femoral nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail is typically inserted into the femoral canal using either a retrograde or antegrade surgical approach. The T2 Femoral Nail is currently available in diameters ranging from 8 to 15 mm and lengths ranging from 140 to 480 mm. Additional sizes will offer 16 and 17 mm diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral canal, femur, hip joint, knee
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)
Mechanical testing has been performed on the worst case predicate T2 Femoral Nails to demonstrate the increased diameter of the T2 femoral nails are substantially equivalent to the subject devices. This, the engineering analysis based on component strength, moment of inertia of the additional sizes demonstrate the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K081152, K021744, K014220, K010801
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.
Not Found
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).
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
AUG - 8 2011
K 112059
510(k) Summary of Safety and Effectiveness: T2 Nail
T2 Femoral Nail Proprietary Name: Intramedullary Nail, Femoral Nail Common Name: Intramedullary Fixation Rod, 21 CFR §888.3020 Classification Name and Reference: Class II Proposed Regulatory Class: HSB Product Codes: Valerie Giambanco For Information contact:
Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Manwall, NJ 671-6275 Fax: (201) 831-3275
Date Prepared:
7/15/2011
Legally Marketed Device to Which Substantial Equivilance is Claimed:
T2 Femoral Nail System: K081152, K021744, K014220, K010801
Description:
Description:
The T2 Femoral nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to aconnocated a The T2 Femoral nail is a cylindrial, cambian and the femoral canal using either a retrograde of shape of the femu: The T2 Femoral Nail is currently available in diameters ranging from 8 to 15
antegrade surgical approach. The T2 Femoral Nail is currently available in d mm and lengths ranging from 140 to 480 mm.
Additional sizes will offer 16 and 17 mm diameters.
Intended Use:
The modifications do not alter the intended use of the predicate system as cleared in the referenced The modifications do not alter the nie presents a fixetion device compised of femoral
premarket notifications. The T2 Femoral Nail System is a fraction of Nail System is premarket notifications. The 12 Femoral Nati System is a The T2 Femoral Nail System is
nails and the related locking screws, compression screation with soft tissue irritatio nails and the related locking screws, compression with minimal soft tissue irritation. This intended to provide strong and stable meeting not as a substitute for normal intact bone and tissue.
2
1
Indications for Use:
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:
X112054
3
- · Open and closed femoral fractures
- · Pseudoarthrosis and correction osteotomy
- · Pseudoarthrosis and correction visioners and tumor resections
Pathologic fractures, impending pathologic fractures, exicular extension - Painologic fractures, including those with intra-articular extension
Supracondylar fractures, including those with intra-articular extension
Supracondylar fractures, in - · Ipsilateral femur fractures
- · Fractures proximal to a total knee arthroplasty
- Fractures distal to hip joint
- Nonunions and malunions
Proposed Modification:
Proposed Modification:
The subject T2 Femoral Nails have the same intended use, material, and operational The subject T2 Femoral Nails have the same multiplikes of 0.0.152, K021744, K014220, and
principles as the previously cleared T2 Femoral Nation Colditions Larger dizes of 16 principles as the previously cleared it Femoral Natis Clear of Career izes of 16 and 17mm. The
K010801. The subject T2 Femoral device consists of the nails with a radius of S K010801. The subject T2 Femoral device consists of administrations with a radius of 3m and
lengths will continue to range from 140-480mm in 20mm increments for the nails with lengths will comm for the nails with a radius of 1.5m.
Summary of Data:
:
Mechanical testing has been performed on the worst case predicate T2 Femoral Naily equivalent subject devices Mechanical testing has been performed on the more as a beantialy equivalent subject devices
demonstrates the increased diameter of the T2 femoral naily equivalent subject dev demonstrates the increased diameter of the life in the subs... This, the enginesing andysis of
based on component strength, moment of increases arber the safety and based on component strength, moment of the the additional sizes do not affec the safety and the new 16 and 17mm diameter sizes demonstral include anatomical fit of the new diameter. These risks
effectiveness of the device. Potential risks andres fFMFA and mechanical effectiveness of the device. Potential issues android (RMEA) and mechanical testing which have been investigated with use of failure mode cries and your was your affect device performance.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, possibly representing health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Valerie Giambanco 325 Corporate Drive Mahwah, New Jersey 07430
AUG - 8 2011
Re: K112059
Trade/Device Name: T2 Femoral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 15, 2011 Received: July 19, 2011
Dear Ms. Giambanco:
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
3
Page 2 – Ms. Valerie Giambanco
device-related adverse events) (21 CFR 803): 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. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours
e
Mark N. Melkerson 1 Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k)
Indications for Use
510(k) Number (if known): K 11205 9
Device Name: T2 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
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (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)
M. Melleer
Page 1 of 1
(Division Sign-Of (Division Sign-Or), Orthopedic, Division of Restorative Devices
510(k) Number K112059
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