The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.

The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

Open and closed tibial fractures
Pseudoarthodosis and correction osteotomy
Pathologic fractures, impending pathologic fractures, and tumor resections
Nonunion and malunion

Device Description

This Traditional 510(k) submission is being supplied to the US FDA to include a modified targeter device and its components as Class II accessories as part of the Suprapatellar Instrument (SPI) System included in the T2 Tibial Nailing System, previously cleared under K003018 as the Titan Tibial Nail. The T2 Tibial Nailing System was determined substantially equivalent via 510/k) K003018 and included tibial nails and associated accessories such as locking screws. compression screws and end caps. There are three nail designs for the T2 Tibial Nail: Proximal. Standard, and Distal. These T2 tibial nails are fabricated from titanium and are available sterile. The T2 tibia targeter devices are intended to be used as part of the T2 Tibial Nailing System. In addition, this submission addresses a modification made to some components of the targeting device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the T2 Tibial Nailing System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Standard	Reported Device Performance
Mechanical Performance	Stiffness Testing	Substantially equivalent to predicate device
	Bending Load	Substantially equivalent to predicate device
	Transferable Torque of Connections	Substantially equivalent to predicate device
	Transferable Torque between Nail and Nail Adapter	Substantially equivalent to predicate device
	Impulse Test	Substantially equivalent to predicate device
	Drop Test	Substantially equivalent to predicate device
Biocompatibility/Safety	(Not explicitly stated, assumed to be covered by predicate)	"The subject device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices."
Functional/Clinical	Cadaveric Testing	Substantially equivalent to predicate device
	Clinical Testing	Not required for this submission

Explanation of the Acceptance Criteria and Performance:

The primary acceptance criterion used for the T2 Tibial Nailing System, particularly for the modified targeter device and its components, was substantial equivalence to legally marketed predicate devices. This means that the new device, when subjected to the same tests as the predicate, performed comparably and met the established standards. The reported device performance for all non-clinical tests (Stiffness, Bending Load, Torque, Impulse, Drop, Cadaveric) was that the subject device (the modified targeter and its components) was "substantially equivalent to the predicate device currently cleared for marketing."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text for any of the non-clinical tests. For cadaveric testing, a sample size would typically be mentioned, but it is not here.
Data Provenance: The testing was "Non-clinical laboratory testing" and "Cadaveric Testing." There is no indication of country of origin for the data or whether it was retrospective or prospective, though non-clinical lab and cadaveric testing are inherently prospective in nature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable (N/A) as no clinical study requiring expert ground truth assessment was performed. The evaluation relied on non-clinical engineering and cadaveric testing, and a determination of substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) as no clinical study requiring adjudication of expert opinions was performed.

5. 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 device is a medical implant (intramedullary fixation rod, targeter) and does not relate to AI or human image interpretation. Therefore, this question is not applicable to the submitted information.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done.
This device is a medical implant and mechanical accessory, not an algorithm or AI device. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by engineering standards and benchmarks derived from the performance of the predicate device. The goal was to demonstrate that the new device's performance (e.g., stiffness, bending load, torque) met or exceeded these established benchmarks, indicating substantial equivalence.
For the cadaveric testing, the "ground truth" would be related to the anatomical and mechanical outcomes observed during the procedure, demonstrating the device's functional performance in a simulated surgical environment compared to the predicate.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a training set. The evaluation was based on non-clinical testing of physical components.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable (N/A) as there was no training set for an AI/ML algorithm.

Summary

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510(k) Summarv

T2 Tibial Nailing Svstem Proprietary Name: Intramedullary Fixation Rod Common Name: Rod. Fixation. Intramedullary and Accessory 21 CFR Classification Name and Reference: $888.3020 Proposed Regulatory Class: Class II OCT 1 0 2013 Product Codes: H&B For Information Contact: Estela Celi, RAC Regulatory Affairs Specialist Stryker Trauma AG 325 Corporate Drive Mahwah. NJ 07430 Phone: (201) 831-6461; Fax (201) 831-3461 Legally Marketed Devices to Which K003018 - Titan Tibial Nail K111667 - Synthes Suprapatellar Insertion Substantial Equivalence Is Claimed: Instruments Date Prepared: August 30, 2013

Description

Intended Use

The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunion, and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically, and compression locked.

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Indications

The T2 Tibial Nailing System is indicated for long bone fracture fixation. specifically tibial fracture fixation, which may include the following:

o Open and closed tibial fractures
· Pseudoarthodosis and correction osteotomy
Pathologic fractures, impending pathologic fractures, and tumor resections .
Nonunion and malunion .

Summary of Technologies

The subject device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices. Inclusion of the targeter device and its components as accessories to the T2 Tibial Nailing System does not alter the device technology.

Non-Clinical Testing

Non-clinical laboratory testing was performed on the targeting device and its components to determine substantial equivalence. Testing demonstrated that the subject targeter device is substantially equivalent to the predicate device currently cleared for marketing. The following testing was performed:

Stiffness Testing .
Bending Load o
o Transferable Torque of Connections
. Trunsferable Torque between Nail and Nail Adapter
0 Impulse Test
. Drop Test
o Cadaveric Testing

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The T2 Tibial Nailing System and its components are substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

October 10, 2013

Stryker Trauma AG Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K131365

Trade/Device Name: T2 Tibial Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 13, 2013 Received: September 13, 2013

Dear Ms. Celi:

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

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Page 2 - Ms. Estela Celi

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 (30!) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Erin | Keith

for

Mark Melkerson

Director
Division of Orthopedic Devices Office of Device Evaluation Center for Devices and
Radiological Health

Enclosure

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Indications for Use

KI31365 510(k) Number (if known):

Device Name: T2 Tibial Nailing System

Indications for Use:

The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

Open and closed tibial fractures .
Pseudoarthodosis and correction osteotomy .
Pathologic fractures, impending pathologic fractures, and tumor resections �
Nonunion and malunion .

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Rh.D.
Division of Orthopedic Devices

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.