The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); . e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
Correctable valgus-varus deformity and moderate flexion contracture. .

Device Description

The CoCr tibial baseplate, manufactured from cast CoCr alloy (ASTM-F-75), is a nonporous, stemmed configuration and intended for cemented use only. The CoCr tibial baseplate is anatomic and asymmetric in design, available in sizes 00-5 and left and right configurations.

AI/ML Overview

The provided document is a 510(k) summary for the Sulzer Orthopedics Inc. Natural Knee II System CoCr Tibial Baseplate, dated August 9, 2002. This document is a regulatory submission for a medical device and therefore does not contain information about acceptance criteria for device performance as it would be understood for a diagnostic AI/ML device, nor does it describe a study proving the device meets performance criteria in the context of AI/ML.

This document is for a mechanical medical device (a knee implant), not a diagnostic AI/ML device. Therefore, the questions posed, which are designed for assessing AI/ML device performance studies, do not directly apply to the content of this 510(k) submission.

Specifically:

Acceptance criteria and reported device performance (Table): Not applicable for this type of device and document. Regulatory approval for such a device is based on "substantial equivalence" to a predicate device, which means demonstrating similar technology, materials, and intended use as a device already on the market. There are no performance metrics like sensitivity, specificity, or AUC as expected for an AI/ML diagnostic.
Sample size and data provenance (test set): Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation.
Number of experts and qualifications (ground truth): Not applicable. Ground truth, as defined for AI/ML, is not relevant here. Device safety and efficacy are typically supported by mechanical testing, biocompatibility studies, and comparison to predicate devices, not expert consensus on diagnostic interpretations.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance in diagnostic tasks.
Standalone algorithm performance: Not applicable.
Type of ground truth: Not applicable.
Sample size for training set: Not applicable. This device is not an AI algorithm that undergoes training.
How ground truth for training set was established: Not applicable.

Summary based on the provided document:

The Natural-Knee II CoCr Tibial Baseplate is a mechanical orthopedic implant, specifically a component for total knee arthroplasty. Its approval relies on demonstrating substantial equivalence to an already legally marketed predicate device (the Natural Knee II System Non-porous Stemmed Tibial Baseplate) in terms of general design, intended use, and indications for use. The document specifies that the new device is manufactured from cast CoCr alloy (ASTM-F-75), is nonporous, stemmed, and intended for cemented use only. It is anatomic and asymmetric, available in sizes 00-5 and left/right configurations.

Indications for use include treatment of Noninflammatory Degenerative Joint Disease (e.g., avascular necrosis, osteoarthritis) and Inflammatory Joint Disease (e.g., rheumatoid arthritis), as well as correctable valgus-varus deformity and moderate flexion contracture in skeletally mature individuals.

Summary

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Q21578
page 1 of 1

AUG 0 9 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENES

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Inc. Natural Knee II System CoCr Tibial Baseplate.

Submitter:	Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900
Date:	May 13, 2002
Contact Person:	Frances E. HarrisonManager, Regulatory Projects
Classification Name:	Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, 21 CFR 888.3560
Common/Usual Name:	Knee Prosthesis, Partially Constrained
Trade/Proprietary:	Natural-Knee® II System CoCr Tibial Baseplate

PRODUCT DESCRIPTION

SPECIFIC DIAGNOSTIC INDICATIONS

The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

മ Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD): e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
D Correctable valgus-varus deformity and moderate flexion contracture.

SUBSTANTIAL EQUIVALENCE

The Natural Knee II CoCr Tibial Baseplate is to the following commercially available in devices in terms of general design, intended use and indications for use:

O Natural Knee II System Non-porous Stemmed Tibial Baseplate

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The overall design is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 9 2002

Ms. Frances E. Harrison, RAC Manager, Regulatory Projects Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K021578

Trade/Device Name: Natural-Knee II CoCr Tibial Baseplate Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 13, 2002 Received: May 14, 2002

Dear Ms. Harrison:

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. Frances E. Harrison, RAC

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" (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 A. Milburn

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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Image /page/3/Picture/1 description: The image shows the text '510(k) Number (if known):' followed by the number 'KO21578'. This indicates that the image is likely part of a document or form related to medical device regulation, specifically the 510(k) premarket notification process. The number 'KO21578' is the 510(k) number assigned to a specific medical device.

Device Name: Natural-Knee IL System

Indications for Use:

The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); . e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
Correctable valgus-varus deformity and moderate flexion contracture. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

Mark A. Milliman (Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurologic Devices

510(k) Number K021578

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.