These devices are fracture fixation devices comprised of femoral and tibial nails and the related accessories such as locking screws, compression screws, end caps, condyle screws, and a condyle screw nut. The S2 tibial nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The S2 femoral nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the femur.

S2 Tibial Nail: The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Nonunion and malunion.

S2 Femoral Nail: The S2 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 a hip joint, Nonunions and malunions.

Device Description

This Traditional 510(k) submission is being supplied to the US FDA to include targeter devices as accessories to the S2 Nail System that was cleared under K032579.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the S2 Nail System, based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Reported Device Performance
Implantation without complications in human cadaveric lab.	"the S2 nails were implanted using the targeter and other relevant components without any complications, demonstrating that products are performing as intended."
Modifications to existing nail adapter do not introduce a worst-case scenario for product performance (bench testing).	"bench testing conducted showed that the modifications made to the existing nail adapter does not introduce worst case scenario for product performance."

Study Details

Sample sizes used for the test set and the data provenance:
- Test set: Not explicitly stated as a numerical sample size. The text mentions a "human cadaveric lab." For the bench testing, no sample size is provided.
- Data provenance: Not specified beyond "human cadaveric lab." No country of origin is mentioned, and the nature of the cadaveric lab (retrospective or prospective) isn't detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated. The testing was conducted in a "human cadaveric lab," which implies involvement of individuals with surgical or anatomical expertise, but their exact number and qualifications are not provided.
- Qualifications of experts: Not explicitly stated.
Adjudication method for the test set:
- Not applicable as the testing described is primarily observational (cadaveric lab, bench testing) rather than involving subjective interpretation requiring adjudication.
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 medical implant, not an AI diagnostic tool, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm-only performance study was done. This device is a physical implant, not a software algorithm.
The type of ground truth used:
- For the cadaveric lab, the "ground truth" was the successful, complication-free implantation of the device as assessed by the operators.
- For the mechanical tests, the "ground truth" was adherence to engineering performance standards demonstrating that modifications did not worsen performance.
The sample size for the training set:
- Not applicable. This submission is for a physical medical device (intramedullary nail system), not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI algorithm was used.

Summary of the Study:

The provided document describes non-clinical testing performed for the S2 Nail System to support its substantial equivalence to predicate devices. This testing did not involve clinical trials or studies related to AI or diagnostic performance. Instead, it focused on:

Cadaveric Study: Implantation of the S2 nails (with targeters) into human cadavers to ensure the devices could be used as intended without complications. This served as a practical demonstration of functionality.
Mechanical/Bench Testing: Evaluation of modifications made to the existing nail adapter to ensure these changes did not negatively impact the product's performance or introduce new risks.

The conclusion drawn from these tests was that the S2 Nail System, including the new targeter devices, is substantially equivalent to the predicate devices and performs as intended. Clinical testing was explicitly stated as "not required for this submission."

Summary

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FEB 1 5 2012

510(k) Summary of Safety and Effectiveness

Proprietary Name:	S2 Nail System
Common Name:	Intramedullary Fixation Rod
Classification Name and Reference:	Intramedullary Fixation Rod21 CFR §888.3020
Proposed Regulatory Class:	Class II
Product Codes:	87HSB: Rod, Fixation, Intramedullary and Accessory
For Information Contact:	Juma HoshinoRegulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah. NJ 07430Phone: (201) 831-5992; Fax (201)831-4992
Legally Marketed Devices to WhichSubstantial Equivalence Is Claimed:	K032579 - S2 Nail SystemK 102992 – T2® Recon Nail System
Date Prepared:	November 17, 2011

Description

This Traditional 510(k) submission is being supplied to the US FDA to include targeter devices as accessories to the S2 Nail System that was cleared under K032579.

Intended Use

Indications

S2 Tibial Nail

The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

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

S2 Femoral Nail

The S2 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 a hip joint .
. Nonunions and malunions

Summary of Technologies

The proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device. Inclusion of targeter devices as an accessory to the S2 Nail System does not alter the technology.

Non-Clinical Testing

A human cadaveric lab and mechanical tests were conducted. For the human cadaveric lab, the S2 nails were implanted using the targeter and other relevant components without any complications, demonstrating that products are performing as intended. In addition, bench testing conducted showed that the modifications made to the existing nail adapter does not introduce worst case scenario for product performance.

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The S2 Nail System devices are substantially equivalent to the predicate devices identified in this premarket notification.

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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 stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Juma Hoshino 325 Corporate Drive Mahwah, New Jersey 07430.

Re: K113409

Trade/Device Name: S2 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 17, 2011 Received: November 18, 2011

FEB 15 2012

Dear Ms. Hoshino:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) pressure is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars) to regars and the Medical Device Americal Drug commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that do not require approvince to the general controls provisions of the Act. The You may, therefore, market the devices, belyer to the more of registration, listing of general controls provisions of the fict labeling, and prohibitions against misbranding and devices, good manufacturing practice, not evaluate information related to contract liability adulteration. Please note: CDAT does not evaluate include ing must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) into time major regulations affecting your device can be may be subject to additional controls: "Entrally any of to 898. In addition, FDA may lound in the Oode of I ouch 11 concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backers with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delerimiation that Jour as reserved by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Part 807), labeling (21 CFR 803); models and manufacturing practice requirements as set

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Page 2 - Ms. Juma Hoshino

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in alle qualisms of trovisions (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 n you active you .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 I ou may obtain other generational 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,
Mark M. Mellers

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

Enclosure

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Indications for Use

510(k) Number (if known): _ K1134096pg 1/1)

Device Name: S2 Nail System

S2 Tibial Nail

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

S2 Femoral Nail

The S2 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 a hip joint .
Nonunions and malunions .

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)

Page 1 of 1

Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113409

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.