· Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
· Patients with failed previous surgery where pain, deformity, or dysfunction persists
Correctable varus-valgus deformity and moderate flexion contracture
· Revision of a previously failed knee arthroplasty
· Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur with Cobalt 3D®, and the Klassic® Tibial Baseplate with Ti-Coat® which are indicated for cementless use.

Device Description

The purpose of this Special 510(k) is to add the Klassic® Tibial Inserts, PS-Max®, an additional posterior stabilizing design option, to the Klassic® Knee System (K112906). The Klassic® Tibial Inserts, PS-Max® are available in various sizes and thicknesses to match patient anatomy and provide surgical options.

AI/ML Overview

This submission describes the Klassic® Knee System Tibial Inserts, PS-Max®, a medical device intended for prosthetic replacement in knee arthroplasty. The submission is a Special 510(k), meaning it aims to add a new design option to an already cleared Klassic® Knee System (K112906). The primary goal is to demonstrate substantial equivalence to a predicate device, the Klassic® Tibial Inserts, PS-Post™ (K183596).

Here's the breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the subject device met pre-determined acceptance criteria for various verification activities. However, it does not explicitly list the quantitative acceptance criteria or the specific reported device performance values in a table format within the provided text. It generally states that the device "met the pre-determined acceptance criteria" and that "the results of analysis and testing indicate that the subject tibial inserts are substantially equivalent to the predicate components."

The types of tests performed indicate the areas for which performance criteria would have been established:

Acceptance Criteria Category	Reported Device Performance
Femoral/Tibial Stability Characteristics	Indicated to be substantially equivalent to the predicate. (Specific values not provided)
Contact Stress Evaluation	Indicated to be substantially equivalent to the predicate. (Specific values not provided)
Range of Motion	Indicated to be substantially equivalent to the predicate. (Specific values not provided)
Knee Simulator Wear	Indicated to be substantially equivalent to the predicate. (Specific values not provided)
Tibial Insert Post Strength and Fatigue	Indicated to be substantially equivalent to the predicate. (Specific values not provided)
Tibial Insert Modular Disassembly	Indicated to be substantially equivalent to the predicate. (Specific values not provided)
Compliance with LAL requirements for orthopedic implants	"in compliance with LAL requirements for orthopedic implants."

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

The document does not provide details on the sample size used for the test set or the data provenance. It only mentions "Bench testing and engineering analysis were performed." This implies laboratory-based testing rather than clinical data from human subjects.

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

Not applicable. The study appears to be engineering and bench testing, not involving human expert assessment of a test set for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. The study focused on bench testing, which doesn't typically involve adjudication in the clinical sense.

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

No. The document describes bench testing and engineering analysis, not a clinical MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not directly applicable as the device is a physical knee implant component, not a software algorithm. The "standalone" performance here refers to the physical properties of the insert as tested in a lab, separate from human implantation. The bench tests performed are essentially the "standalone" evaluation of the device's physical and mechanical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (physical implant) is established by engineering specifications, industry standards (e.g., LAL requirements), and comparative performance with a legally marketed predicate device. The tests performed (stability, contact stress, range of motion, wear, strength, fatigue, modular disassembly) are designed to assess these physical and mechanical properties against pre-defined engineering targets and the performance of the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable. This is not a machine learning or AI device that requires a "training set."

Summary

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October 9, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Total Joint Orthopedics, Inc. Chris Weaber Director of Research and Development 1567 E. Stratford Avenue Salt Lake City, Utah 84106

Re: K202740

Trade/Device Name: Klassic® Knee System Tibial Inserts, PS-Max® Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. MBH Dated: September 18, 2020 Received: September 18, 2020

Dear Chris Weaber:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K202740

Device Name Klassic® Knee System Tibial Inserts, PS-Max

Indications for Use (Describe)
--------------------------------	--

The Klassic® Knee System is intended for prosthetic replacement of the following:

· Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
· Patients with failed previous surgery where pain, deformity, or dysfunction persists
Correctable varus-valgus deformity and moderate flexion contracture
· Revision of a previously failed knee arthroplasty
· Patients who require a total knee replacement

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106Phone: 801.486.6070Fax: 801.486.6117
Contact:	Mr. Chris WeaberDirector of Research and Development
Prepared By:	MCRA, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	September 18, 2020
Device Trade Name:	Klassic® Knee System Tibial Inserts, PS-Max®
Device Common Name:	PS Inserts
Classification:	21 CFR 888.3560 – Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented21 CFR 888.3565 Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesisClass II
Product Codes:	JWH, MBH

Indications for Use:

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular ● necrosis and osteoarthritis
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis .
Patients with failed previous surgery where pain, deformity, or dysfunction persists
Correctable varus-valgus deformity and moderate flexion contracture ●
Revision of a previously failed knee arthroplasty ●
Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur with Cobalt 3D®, and the Klassic® Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

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Device Description:

Predicate Devices:

The Klassic® Tibial Inserts, PS-Max®, are substantially equivalent to the predicate Klassic® Tibial Inserts, PS-Post™ (K183596) with respect to intended use, design, material, method of fixation and function. The information summarized in the Design Control Activities Summary demonstrates that the subject Klassic® Tibial Inserts, PS-Max®, met the pre-determined acceptance criteria for the verification activities.

Substantial Equivalence:

Bench testing and engineering analysis were performed for the subject Klassic® Tibial Inserts, PS-Max®, to evaluate Femoral/Tibial Stability Characteristics and Contact Stress Evaluation, Range of Motion, Knee Simulator Wear, Tibial Insert Post Strength and Fatigue and Tibial Insert Modular Disassembly. The results of analysis and testing indicate that the subject tibial inserts are substantially equivalent to the predicate components. Additionally, the subject components are in compliance with LAL requirements for orthopedic implants.

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.