(24 days)
Not Found
No
The description focuses on the mechanical properties and design of a physical implant for bone fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a fracture fixation device intended to assist with internal fixation and healing, not to treat a disease or condition in a therapeutic manner.
No
The device is a fracture fixation device, specifically a femoral nail system, used to assist with internal bone fracture fixation. It does not diagnose medical conditions.
No
The device description clearly states the device is a "cylindrical, cannulated titanium alloy tube" and a "fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "long bone fracture fixation, specifically femoral fracture fixation." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "cylindrical, cannulated titanium alloy tube" and related hardware (screws, end caps). This is a physical implant used to stabilize a fracture, not a reagent, instrument, or system used to examine specimens from the human body.
- No mention of biological samples: There is no mention of the device being used with blood, urine, tissue, or any other biological sample.
- Focus on mechanical properties: The performance studies focus on the mechanical properties of the device (bending strength, fatigue strength, etc.), which are relevant to its function as a fracture fixation device, not an IVD.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically stabilize a fractured bone.
N/A
Intended Use / Indications for Use
The subject T2 GTN, like the predicate Osteo IC R/A Femoral Nail System known as the T2 Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The subject and predicate devices are intended to assist with internal fracture fixation with minimal soft tissue irriation. This device is utilized as an aid to healing, not as a subsistute for normal intact bone and tissue.
The subject and predicate devices are 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
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The T2 (Greater Trochanter Nail) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801. The following tests were conducted: Functionality test and influence of cannulated complression screws on the Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, and Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, Screw Insertion Test.
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.
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
K 101438
Special 510(k) Summary of Safety and Effectiveness
'JUN 1 7 2010
| Proprietary Name: | T2 Greater Trochanter Nail (GTN) |
|---|---|
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod |
| 21 CFR §888.3020 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | HSB: Rod, Fixation, Intramedullary and Accessories |
| For Information contact: | Melissa Matarese, Regulatory Affairs Associate |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5116 Fax: (201) 831-4116 |
Date Prepared:
June 17, 2010
Predicate Device Identification
The T2 (Greater Trochanter Nail) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
Description of Device Modification
The predicate device is the T2 Femnoral Nail A/R which was cleared for sale under K010801 in April 2001. The intended use and indications are the same. The difference between T2 GTN and the predicate is that the nail entry point is in the grater trochater for T2 GTN, whereas for the T2 Femoral Nail A/R it is in the piriformisfossa.
Intended Use
The subject T2 GTN, like the predicate Osteo IC R/A Femoral Nail System known as the T2 Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The subject and predicate devices are intended to assist with internal fracture fixation with minimal soft tissue irriation. This device is utilized as an aid to healing, not as a subsistute for normal intact bone and tissue.
Indications for Use
The subject and predicate devices are indicated for long bone fracture fixation, specifically
femoral fracture fixation, which may include the following:
- p. 1 of 2
1
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy ●
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Ipsilateral femur fractures ●
- Fractures proximal to a total knee arthoplasty .
- Nonunions and malunions .
Statement of Substantial Equivalence:
Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801. The following tests were conducted: Functionality test and influence of cannulated complression screws on the Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, and Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, Screw Insertion Test.
. p. 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. c/o Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
Re: K101438
Trade/Device Name: T2 Greater Trochanteric Nail (GTN) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: May 19, 2010 Received: May 24, 2010
JUN 1 7 2010
Dear Ms. Matarese:
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. Melissa A. Matarese
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/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,
Barbara Buelun
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): K |(143
Device Name: T2 GTN
Indications For Use:
The subject and predicate devices are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- ତ Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy 9
- Pathologic fractures, impending pathologic fractures, and tumor resections �
- Ipsilateral femur fractures o
- Fractures proximal to a total knee arthroplasty ග්රී
- Nonunions and malunions 0
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)
Page 1 of 1
Omtte for mxm
(Division Sign-Off)
ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101438