WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW by HOWMEDICA OSTEONICS CORP.

This device is intended for use with the Wichita™ Fusion Nail in cases for intramedullary knee arthrodesis is performed to relieve pain and to stabilize a knee joint that has been severely damaged as a result of trauma, infection, or failed previous surgeries (including previous total joint replacement). More specific indications include treatment of the sequelae of septic arthritis in patients who are not candidates for total knee arthroplasty, irretrievably failed total knee arthroplasty (either septic or aseptic), Charot arthropathy, painful degenerative knee in patients who are not candidates for total knee arthroplasty, arthrodesis of the knee for salvage in tumor surgery, delayed or non-union after previous arthrodesis of the knee, and any other condition where arthrodesis is the treatment of choice.

Device Description

This Special 510(k) submission is intended to address a design modification to the predicate Wichita™ screw. The predicate device is a partially threaded screw manufactured from wrought Vitallium® (CoCr) Alloy which conforms to ASTM standard F1537. This device was found substantially equivalent via the 510(k) process. The subiect device is being modified from a partially threaded screw with course thread design to a fully threaded screw with fine thread design. The screw head length is being reduced by 1mm, and the head profile is changing from the square to the rounded design. Additionally, a 25mm screw will be added to the current product line. The intended use of the Wichita™ Fully Threaded Self-Tapping Screw is identical to the Wichita™ Partially Threaded Self-Tapping Screw.

AI/ML Overview

This document is a 510(k) submission for a device modification, specifically for the Wichita™ Fusion Nail Fully Threaded Self-Tapping Screw. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way typically seen for diagnostic or AI-enabled devices.

The information provided describes:

Device: Wichita™ Fusion Nail Fully Threaded Self-Tapping Screw.
Modification: From a partially threaded screw with a coarse thread design to a fully threaded screw with a fine thread design. Also, a 1mm reduction in screw head length, changing the head profile from square to rounded, and adding a 25mm screw to the product line.
Intended Use: Identical to the predicate device, for intramedullary knee arthrodesis in cases of severe knee damage due to trauma, infection, or failed surgeries, and other specific indications like septic arthritis, failed total knee arthroplasty, and Charcot arthropathy.
Regulatory Outcome: The FDA found the device substantially equivalent to a predicate device, allowing it to be marketed.

Therefore, the questions you've asked, which are relevant to evaluating the performance of a diagnostic device or an AI algorithm, cannot be answered from the provided text.

Here's why and what kind of information would be needed to answer your questions:

Acceptance Criteria & Reported Performance: This document is about a design modification to a physical implant. The "acceptance criteria" here would relate to manufacturing specifications, material properties, and mechanical strength, not diagnostic performance metrics like sensitivity, specificity, or AUC. A study proving conformance would be mechanical testing (e.g., fatigue strength, pull-out strength).
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (for Test & Training), Training Set Size: These questions are specific to the evaluation of diagnostic algorithms (especially AI/ML). This document describes a surgical implant, not a diagnostic algorithm. There is no AI component, no "performance" in the sense of accuracy, recall, or precision, and no "ground truth" established by experts for classification tasks.

To summarize, based on the provided text, none of the specific questions regarding acceptance criteria, study design for performance evaluation, or AI-related metrics can be answered. This document is a regulatory submission for a physical medical device modification, demonstrating substantial equivalence rather than performance against a set of diagnostic acceptance criteria.

Summary

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NOV 1 9 1999 Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Wichita™ Fusion Nail Fully Threaded Self-Tapping Screw Wichita™ Fusion Nail Fully Threaded Self-Proprietary Name: Tapping Screw Intramedullary Fixation Rod Common Name: Intramedullary Fixation Rod, Classification Name and Reference: 21 CFR §888.3020 Proposed Requiatory Class: Class II Device Product Code: OR (87) HSB Jennifer A. Daudelin, Regulatory Affairs For Information contact: Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, NJ 07070-2584 (201) 507-7283 Fax: (201) 507-6870

This device is intended for use with the Wichita™ Fusion Nail in cases for intramedullary knee arthrodesis. Arthrodesis is performed to relieve pain and to stabilize a knee joint that has been severely damaged as a result of trauma, infection, or

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K 9 93603

failed previous surgeries (including previous total joint replacement). More specific indications include treatment of the sequelae of septic arthritis in patients who are not candidates for total knee arthroplasty, irretrievably failed total knee arthroplasty (either septic or aseptic), Charot arthropathy, painful degenerative knee in patients who are not candidates for total knee arthroplasty, arthrodesis of the knee for salvage in tumor surgery, delayed or non-union after previous arthrodesis of the knee, and any other condition where arthrodesis is the treatment of choice.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

Ms. Elizabeth A. Staub Vice President Regulatory Affairs, Quality Assurance and Clinical Research Stryker Howmedica Osteonics 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K993603 Re: Wichita™ Fusion Nail Fully Threaded Trade Name: Self-Tapping Screw Requlatory Class: II Product Code: нав Dated: October 4, 1999 Received: October 25, 1999

Dear Ms. Staub:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Elizabeth A. Staub

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberized in formalence of your device to a legally rinding of babban device results in a classification for your marketed produced or mits 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 809.10 for in regaradiagnostic 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 Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K993603 510(k) Number (if known):

Device Name: Wichita™ Fusion Nail Fully Threaded Self-Tapping Screw

Indications for Use:

(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 1-2-96)

bcotteleto

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.