The tibial spacer 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.
. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

Device Description

These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate." It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, statistical analysis, or expert review related to AI/ML or diagnostic performance. The basis of substantial equivalence is stated as "Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device."

Therefore, based only on the provided text, I cannot fill out the requested table or answer the specific questions related to acceptance criteria, diagnostic performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not mentioned in the context of this 510(k) submission.

This document is for a traditional medical device (a knee implant component) and not an AI/ML-driven diagnostic or image analysis tool, which is typically where the "acceptance criteria" and "study proving criteria met" for performance metrics like sensitivity, specificity, or AUC would be detailed. The "performance testing" mentioned likely refers to mechanical and biocompatibility testing common for implantable devices, not diagnostic accuracy.

Summary

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031183

510(k) SUMMARY

SPONSOR NAME:	Centerpulse Orthopedics, Inc.9900 Spectrum DriveAustin, TX 78717
510(k) CONTACT:	Robert M. WolfarthPhone: (512) 432-9324Robert.Wolfarth@Centerpulse.com
TRADE NAME:	Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate
COMMON NAME:	Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
CLASSIFICATION:	Knee joint femorotibial metal/polymer semi-constrained cemented prostheses (Product Code 87 HRY) are Class II per 21 CFR §888.3530, reviewed by the Orthopedic Devices panel.

PREDICATE DEVICE:

The new Tibial Spacer is substantially equivalent to the Centerpulse Orthopedics Natural-Knee® System Tibial Spacer.

DEVICE DESCRIPTION:

INTENDED USE:

The Tibial Spacer 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. .
Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●

BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device.

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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 consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2003

Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K031183 Trade/Device Name: Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 14, 2003 Received: April 15, 2003

Dear Mr. Wolfarth:

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

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Page 2 - Mr. Robert M. Wolfarth

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. 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Stypt Rlwels

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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Indications For Use

KO31183 510(K) Number:

Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate Device Name:

Indications for Use:

The tibial spacer 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.
. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

Division of General, Restorative and Neurological Devices

510(k) Number K031187

(Optional Format 1-2-96)

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.