The S2 Tibial Nail System is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut. 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 S2 Tibial Nail 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.

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

Device Description

The subject S2 Tibial Nail System is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut. 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.

This Special 510(k) submission is intended to address a line extension to the predicate S2 Tibial Nail System. The line extension involves offering larger diameters of the nail. In addition. Condyle Screws, a Condyle Nut and an additional End Cap will be added to the system. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. 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 a line extension to the S2 Tibial Nail System. This document is for a medical device (intramedullary nail) and its purpose is to extend the product line by offering larger diameters and adding new components.

Crucially, the document does not contain details about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the specific information requested in your prompt regarding artificial intelligence (AI) device evaluation.

The text focuses on:

Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification).
Device Description: The line extension involves larger diameters and additional components (Condyle Screws, Condyle Nut, End Cap).
Intended Use: Fracture fixation device for tibial nails and related components, providing strong and stable internal fracture fixation.
Technological Comparison: Stating that the material is identical to the predicate and that FEA analysis and mechanical testing demonstrate comparable mechanical properties. This is the closest the document comes to mentioning any form of "study" or "performance."
FDA Communication: A letter from the FDA confirming substantial equivalence to a predicate device.
Indications For Use: Specific types of tibial fractures and conditions for which the device is indicated.

Since the document is about a mechanical orthopedic implant and not an AI-powered device, it does not include the type of information you've asked for within the context of AI device evaluation (e.g., test set, ground truth, MRMC study, standalone performance).

Therefore, I cannot extract the requested information (points 1-9) from the provided text.

Summary

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AUG 26 2002

K022481
page 1 of

Special 510(k) Summary: Line Extension to the S2 Tibial Nail System

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
Contact Person:	Karen AriemmaRegulatory Affairs Specialist
Date of Summary Preparation:	July 26, 2002
Device Identification
Proprietary Name:	S2 Tibial Nail

Common Name:	Intramedullary Nail, Tibial Nail
Classification Name and Reference:	Intramedullary Fixation Rod, 21 CFR §888.3020

Intended Use

Statement of Technological Comparison:

The material used to manufacture the line extension to the S2 Tibial Nail System is identical to that of the predicate. FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate devices.

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Image /page/1/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

AUG 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corporation Karen Ariemma Regulatory Affairs Specialist 59 Route 17 Allendale, New Jersey 07401-1677

Re: K022481

Trade/Device Name: S2 Tibial Nail Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 26, 2002 Received: July 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 (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. 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 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 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" (21 CFR 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.

Sincerely yours,

O Mark n Mullens

Celia M. 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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510(k) Number (if known): K Ox JY 8

Device Name: S2 Tibial Nail System

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-96)
Mark H-Mather

(Division Sign-Off)
Division of General, Restorative

Neurological Devices

510(k) Number K022481

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.