The S2TM Recon Nail System 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

This Special 510(k) submission is intended to address a material modification and a design modification of the T2™ Recon Nail System to create the subject device, which is referred to as the S2TM Recon Nail System. The material modification involves changing the material from Titanium alloy to Stainless Steel with design changes based on the S2™ Femoral and T2TM Recon Nails. There is no change in intended use for the modified device when compared to the previously cleared device.

AI/ML Overview

The provided text describes a Special 510(k) submission for the S2™ Recon Nail System, which is a fracture fixation device. The submission aims to demonstrate substantial equivalence to a predicate device, the T2™ Recon Nail System, after a material and design modification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Properties	Comparable mechanical properties to the predicate T2™ Recon Nail System (implied to ensure safe and effective fracture fixation)	"Mechanical testing demonstrated comparable mechanical properties to the predicate components and established substantial equivalence."

Study Information

Sample size used for the test set and the data provenance:
The document does not specify a "test set" in terms of patient data. The study mentioned is "mechanical testing" of the device itself. No details are provided regarding the sample size of tested components or the provenance of any data beyond that it relates to the physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The study involved mechanical testing of the device, not an evaluation requiring expert consensus on a clinical test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for studies involving human judgment or interpretation, which is not the case for the mechanical testing described.
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 MRMC comparative effectiveness study was done. This device is a physical medical implant (intramedullary nail), not an AI-assisted diagnostic or therapeutic tool for which such a study would be relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical implant, not an algorithm. The "standalone" assessment was mechanical testing of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" would be engineering specifications and performance benchmarks derived from the predicate device. The text explicitly states, "comparable mechanical properties to the predicate components," implying the predicate's performance serves as the benchmark.
The sample size for the training set:
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no concept of a "training set" in this context.
How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned.

Summary of the Study:

The study proving the device meets the acceptance criteria was a mechanical testing comparison. The S2™ Recon Nail System underwent mechanical testing to demonstrate that its properties are comparable to those of the predicate device, the T2™ Recon Nail System. This mechanical equivalence was sufficient to establish "substantial equivalence" for the purpose of the 510(k) submission, confirming that the material and design modifications did not negatively impact the device's functional performance relative to the legally marketed predicate. The exact parameters of the mechanical tests (e.g., torsion, bending, fatigue strength) and their specific numerical acceptance criteria are not detailed in the provided text, but the conclusion is that "comparable mechanical properties" were achieved.

Summary

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APR 1 3 2006

Summary of Safety and Effectiveness S2TM Recon Nail System

Proprietary Name:	S2™ Recon Nail System
Common Name:	Intramedullary Nail
Classification Name and Reference:	Intramedullary Fixation Rod
	21 CFR §888.3020
Device Product Code:	87 HSB
For Information contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038
Date Summary Prepared:	March 31, 2006

Description:

Intended Use:

The subject S2TM Recon Nail System, like the predicate T2™ Recon Nail System, is a fracture fixation device comprised of femoral nails and related components. The subject and predicate devices are intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is used as an aid to healing, not as a substitute for normal intact bone and tissue. The indications for use provided below are exactly the same as the T2TM Recon Nail System's indications.

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ko60921 p. 2/2

Indications for Use:

The S2™ Recon Nail System 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.

Substantial Equivalence:

The subject S2™ Recon Nail System shares the same intended use, and basic design concepts as that of the currently available T2™ Recon Nail System. Mcchanical testing demonstrated comparable mechanical properties to the predicate components and established substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2006

Howmedica Osteonics Corporation c/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K060921

Trade/Device Name: S2™ Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 31, 2006 Received: April 4, 2006

Dear Mr. Haro:

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

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Page 2 - Mr. Francisco Haro

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
elmale

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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bu921

510(k) Number (if known):

Device Name: S2TM Recon Nail System

Indications for Use:

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

Concurrence H, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices

Ko60921 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.