The T2® Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are 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® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Device Description

The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate design of Set Screw to the system. There is no change in intended use for the subject device, which is provided below.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (T2® Recon Nail System Line Extension) and does not contain detailed information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically found for AI-driven or diagnostic devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. For medical implants like this, the "study" is primarily mechanical and functional testing, and "acceptance criteria" are based on meeting established standards or demonstrating equivalence to the predicate device's performance.

Here's an attempt to extract the information you requested, based on the provided text, and highlighting what is not available in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit from Submission)	Reported Device Performance (Summary)
Material Composition	Same materials as predicate device.	Made from titanium alloy and PEEK.
Intended Use	Same intended use as predicate device.	No change in intended use.
Indications for Use	Same indications for use as predicate device.	Same indications for use.
Mechanical & Functional Properties	Comparable to predicate device.	Demonstrated comparable mechanical & functional properties to the predicate device.

Note: For a device like an intramedullary nail, specific numerical acceptance criteria (e.g., fatigue strength, torsional stiffness, bending strength) would be defined in testing protocols but are not detailed in this 510(k) summary. The summary focuses on assuring the FDA that the new device performs "comparably" to the already-cleared predicate.

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

This information is not available in the provided 510(k) summary. For mechanical tests, the "sample size" would refer to the number of devices tested, not human subjects or data sets. The data provenance would be from internal lab testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to this type of device submission. Ground truth, in the context of device performance, relates to mechanical and material properties, not expert-derived clinical outcomes or image interpretations.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. Adjudication methods are typically used for clinical endpoints or image interpretation, not for mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable to this type of device. MRMC studies are used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance Study

This is not applicable to this type of device. There is no algorithm for this implant.

7. Type of Ground Truth Used

For this device, the "ground truth" would be established through engineering standards, material specifications, and validated mechanical testing methods. The performance of the predicate device would also serve as a reference for comparison.

8. Sample Size for the Training Set

This is not applicable to this type of device. There is no "training set" in the context of mechanical device testing; this term applies to machine learning algorithms.

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

This is not applicable for the same reasons as above.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the study that proves the device meets acceptance criteria is:

Functional and mechanical testing: "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject T2® Recon Nail System to the predicate device."

The core thrust of this 510(k) submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (also the T2® Recon Nail System, but presumably an earlier version or one without the new set screw design). The "acceptance criteria" are thus implicitly met if the new design performs comparably to the predicate device in terms of materials, intended use, indications for use, and mechanical/functional properties. Specific test results and detailed criteria are usually found in the full 510(k) submission, not typically in the public summary.

Summary

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DEC 1 8 2008

Special 510(k)

K083437

/ .

510(k) Summary of Safety and Effectiveness: T2® Recon Nail System Line Extension

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Avital Merl-Margulies, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6365 Fax: (201) 831-6038

Date Summary Prepared:

November 10, 2008

Device Identification

Proprietary Name: Common Name: Classification Name and Reference: T2® Recon Nail System Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR §888.3020 87 HSB

Device Product Codc:

Description:

Intended Use:

The subject 120 Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are 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:

Statement of Technological Comparison:

The subject and prodicate devices are made from titanium alloy and PEEK. Functional and mechanical testing demonstrates the comparable mechanical & functional propertics of the subject T2® Recon Nail System to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2008

Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430

Re: K083437

Trade/Device Name: 120 Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 10, 2008 Received: November 20, 2008

Dear Ms. Merl-Margulies:

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. Avital Merl-Margulies

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 Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding 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 yours.

Mark H. Milliken

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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Indications for Use

510(k) Number (if known): K083437

Device Name: T2® Recon Nail System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(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

ign-01 Division of General, Restorative, and Neurological Devices

10683432

510(k) Number.

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.