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 fixation with minimal soft tissue irritation. This device is intended to provide fixation 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

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the T2 Femoral Nail, formatted as requested.

Introduction:

The provided document describes a 510(k) submission for modifications to the T2 Femoral Nail system, specifically the introduction of larger diameters (16 and 17 mm). The submission asserts that these modifications do not alter the intended use, material, or operational principles of the previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document implicitly defines the acceptance criteria as demonstrating that the modified device (T2 Femoral Nail with 16 and 17 mm diameters) maintains at least equivalent safety and effectiveness to its predicate devices.

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness Equivalence: Proposed modifications (larger diameters) do not affect the safety and effectiveness of the device compared to predicate devices.	Mechanical testing on worst-case predicate and equivalent subject devices showed that the increased diameter increases the component strength and moment of inertia.
Risk Mitigation: Potential risks associated with the new diameters (e.g., anatomical fit) are addressed.	Engineering analysis, Failure Mode and Effects Analysis (FMEA), and mechanical testing investigated potential issues and confirmed they do not adversely affect device performance.

Study Details:

The provided text describes a study that was performed to demonstrate the substantial equivalence of the modified T2 Femoral Nail.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of individual devices. It refers to "worst case predicate T2 Femoral Naily equivalent subject devices" and "the new 16 and 17mm diameter sizes." This implies a limited number of samples representing these specific configurations were tested.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by Howmedica Osteonics Corp. or a contracted lab. It is inherently retrospective in the sense that it evaluates the modified device against pre-existing predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical trials) where expert consensus is needed to define a "ground truth" for diagnostic accuracy. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established "ground truth." The "ground truth" here is the expected mechanical performance and safety profile, established through engineering principles.
Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts. For mechanical testing, results are objective measurements and do not require expert adjudication in this manner.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI systems on human performance, often in diagnostic or imaging contexts. The T2 Femoral Nail is a mechanical implant, and the study described focuses on its physical properties and safety, not on human interpretation or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, essentially a "standalone" performance evaluation was done for the device itself. The study focused purely on the mechanical properties and engineering analysis of the T2 Femoral Nail with the new diameters. There is no algorithm or human-in-the-loop component in this context. The device's performance was evaluated based on its inherent physical characteristics.
The type of ground truth used:
- Engineering Principles, Mechanical Performance Standards, and Predicate Device Performance Data: The "ground truth" for this study is effectively the established safety and effectiveness profile of the predicate devices and general mechanical engineering principles applied to medical implants. The new devices must meet or exceed these established benchmarks.
The sample size for the training set:
- Not applicable/Not mentioned. In the context described, there is no "training set" in the machine learning sense. The device's design is based on established engineering principles and prior device iterations, not on training data for an algorithm.
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned or implied in the context of this mechanical device submission.

Summary

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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.

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Indications for Use:
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:

X112054

· 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.

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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

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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

Mark N. Melkerson 1 Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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

Regulation Number and Section

§ 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.