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

The subject S2 Femoral Nail System, like the predicate T2" Femoral Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. 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.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for the S2 Femoral Nail System, a device that is a design modification to the T2™ Femoral Nail System. This notification is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in the provided document. The submission relies on bench testing (FEA analysis and mechanical testing) to demonstrate comparable mechanical properties to the predicate device, not on clinical performance metrics or human reader studies.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Not explicitly stated as numerical targets, but implied to be comparable to predicate)	Reported Device Performance (Summary from text)
Mechanical Properties	Comparable strength and stability to the predicate T2™ Femoral Nail System.	FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Femoral Nail System to the predicate T2™ Femoral Nail System.
Material	Change from Ti-6A1-4V Alloy to 316L Stainless Steel must maintain equivalent performance.	Material changed from Ti-6A1-4V Alloy to 316L Stainless Steel. (Performance assessed via mechanical comparability).
Design Change (Cross-section)	New cross-section must maintain equivalent performance.	Cross-section changed. (Performance assessed via mechanical comparability).
Design Change (Screw Hole Config.)	New screw hole configuration must maintain equivalent performance.	Proximal and distal screw hole configuration changed. (Performance assessed via mechanical comparability).
Device Lengths	Additional lengths of nails incorporated.	Additional lengths of nails added. (Implies functional equivalence across new lengths).
Intended Use	No change in intended use compared to the predicate device.	No change in intended use for the modified device when compared to the previously cleared device.
Safety/Effectiveness	Implied to be safe and effective for indicated uses, comparable to predicate.	No direct safety/effectiveness metrics for this specific device modification; relies on established safety/effectiveness of predicate.

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

Sample Size: Not applicable. The study was based on FEA analysis and mechanical testing of the device itself, not on biological samples or patient data.
Data Provenance: Not applicable. The data is generated from engineering analysis and laboratory testing.

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

Not applicable. Ground truth in this context would refer to clinical outcomes or expert readings of medical images. The studies performed were engineering-based mechanical evaluations, which do not involve expert ground truthing in the medical sense.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or human adjudication was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No such study was done. This submission is for a medical implant and relies on mechanical testing, not a diagnostic imaging or clinical effectiveness study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This relates to algorithmic performance, which is not relevant to a physical medical implant.

7. The Type of Ground Truth Used

Engineering specifications and mechanical testing standards. The "ground truth" for the mechanical properties would be defined by established engineering principles, material properties, and relevant mechanical testing standards to ensure the new design and material meet performance expectations comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical medical implant undergoing mechanical testing. FEA models might be developed, but they are not "trained" in the machine learning sense.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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S2 Femoral Nail System: Design Modification To The T2™ Femoral Nail Sy

Special 510(k) Premarket Notification

Special 510(k) Summary: S2 Femoral Nail System

Design Modification To The T2™ Femoral Nail System

K021026
page 1 of 1

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677
Contact Person:	Karen Ariemma Regulatory Affairs Specialist

Date of Summary Preparation:

March 28, 2002

Device Identification

Proprietary Name:	S2 Femoral Nail
Common Name:	Intramedullary Nail, Femoral Nail
Classification Name and Reference:	Intramedullary Fixation Rod, 21 CFR §888.3020

This Special 510(k) submission is intended to address a material modification and a design modification of the T2" Femoral Nail System to create the subject device which is referred to as the S2 Femoral Nail System. The material modification involves changing the material from Ti-6A1-4V Allov to 316L Stainless Steel. The design change for the nail involves changing the cross section, changing the proximal and distal screw hole configuration and adding additional lengths of nails. There is no change in intended use for the modified device when compared to the previously cleared device.

Intended Use

Statement of Technological Comparison:

FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Femoral Nail System to the predicate T2™ Femoral Nail System.

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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

d and Drug Administrat 200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

APR 2 5 2002

Re: K021026

Trade/Device Name: S2 Femoral Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 28, 2002 Received: March 29, 2002

Dear Ms. Ariemma:

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 (OS) 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. Karen Ariemma

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 premated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

/ Mark N Millum

Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koolodk

Page 1 of

510(k) Number (if known): K

Device Name: S2 Femoral Nail System

Indications for Use

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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Over-The-Counter Use

(Per 21 CFR 801.109)

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.