· 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

Device Description

The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.

AI/ML Overview

This document is an FDA 510(k) premarket notification for a medical device, the Klassic® Knee System. This type of document is a regulatory submission to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not typically a study report designed to "prove" a device meets specific acceptance criteria in the way a clinical trial or performance study would. It focuses on engineering analyses and comparisons to predicate devices for safety and effectiveness.

Therefore, the requested information elements related to clinical studies, ground truth establishment, expert review, sample sizes for test and training sets, and MRMC studies are largely not applicable or not present in this type of regulatory filing. The "acceptance criteria" here refer to the engineering performance criteria used to demonstrate substantial equivalence, not clinical performance metrics.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Engineering)	Reported Device Performance
Material: Ultrahigh molecular weight polyethylene (UHMWPE)	The new components (All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS®) are manufactured from UHMWPE, consistent with predicate devices and established material for orthopedic implants.
Biocompatibility: LAL (Limulus Amebocyte Lysate) testing	The All-Poly Tibias have undergone LAL testing and are in compliance with requirements for orthopedic implants, ensuring they do not cause clinically significant adverse reactions due to endotoxins.
Mechanical Performance: Contact Area and Surface Stress	Engineering analyses were performed. The results indicate these aspects are substantially equivalent to the predicate components, suggesting similar wear characteristics and load distribution. (Specific numerical criteria not provided in this summary).
Mechanical Performance: Overall Strength	Engineering analyses were performed. The results indicate overall strength is substantially equivalent to the predicate components, suggesting the device can withstand expected physiological loads. (Specific numerical criteria not provided in this summary).
Mechanical Performance: Cement Fixation Features	Engineering analyses were performed. The results indicate cement fixation features are substantially equivalent to the predicate components, implying comparable stability and longevity of the cemented implant. (Specific numerical criteria not provided in this summary).
Design/Function Equivalence to Predicate Devices	The information summarized in the Design Control Activities Summary demonstrates that the subject All-Poly Tibias met the "pre-determined acceptance criteria for the verification activities" by being substantially equivalent to predicate Klassic Knee System (K112906, K140942, K150105, K153075, K153310) and Natural Knee II All-Poly Tibia (K936159).
Intended Use Equivalence to Predicate Devices	The device is intended for prosthetic replacement with bone cement for conditions like NIDJD, IJD, failed previous surgery, correctable varus-valgus deformity, and revision, which are consistent with the predicate indications.
Modular Components with Varying Sizes	The new components are available in sizes to match various patient anatomies, consistent with the modular design of the Klassic Knee System.

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

Not applicable for a clinical test set. The submission refers to "Engineering analyses" for mechanical performance. These analyses would typically involve simulated testing (e.g., finite element analysis, structural testing) rather than a clinical "test set" of patients.
Data Provenance: The analyses are based on engineering principles and relevant standards for orthopedic implants, likely conducted by the manufacturer or a contract lab. Specific countries of origin are not mentioned, but the submission is to the U.S. FDA. The data is pre-market verification.

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

Not applicable. This document describes engineering verification testing, not a clinical study requiring expert ground truth establishment for a diagnostic output.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results by multiple readers. This document outlines engineering test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done including effect size of improvement with AI vs without AI assistance

Not applicable. This device is a total knee replacement system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (knee implant), not an algorithm or software. "Standalone performance" in this context would refer to the mechanical performance of the implant itself, which is what the engineering analyses assess.

7. The Type of Ground Truth Used

Engineering Standards and Predicate Device Performance: The "ground truth" for this type of submission is typically established by recognized engineering standards (e.g., ISO, ASTM for orthopedic implants) and the established performance and safety profile of the legally marketed predicate devices. The new device's engineering performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document does not describe the development of an algorithm or AI model that would require a "training set."

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

Not applicable. As there is no training set for an algorithm, this question is not relevant.

In summary: This FDA 510(k) summary focuses on demonstrating that a modified knee implant system is substantially equivalent to existing predicate devices through engineering analyses and material compliance, rather than presenting a clinical study with detailed patient data, expert reviews, or AI performance metrics.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2016

Total Joint Orthopedics, Inc. Mr. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106

Re: K162422

Trade/Device Name: Klassic® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 30, 2016 Received: September 30, 2016

Dear Mr. 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. 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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162422

Device Name Klassic® Knee System

Indications for Use (Describe)

The Klassic Knee System is intended for prosthetic replacement with the use of bone cement 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 WeaberProduct Development, Regulatory Manager
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: 202.552.5800Fax: 202.552.5798
Date Prepared:	August 29, 2016
Device Trade Name:	Klassic® Knee System
Device Common Name:	Total knee replacement system
Classification:	21 CFR 888.3560 – Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedClass II
Product Code:	IWH

Indications for Use:

The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement 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

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Device Description:

Predicate Devices:

The modified Klassic Knee System is substantially equivalent to the predicate Klassic Knee System (K112906, K140942, K150105, K153075, and K153310) and the Natural Knee II All-Poly Tibia (K936159) with respect to indications, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the subject All-Poly Tibias met the pre-determined acceptance criteria for the verification activities.

Substantial Equivalence:

Engineering analyses were performed on All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to evaluate their contact area and surface stress, overall strength, and cement fixation features. The results of these analyses indicate that the All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® are substantially equivalent to the predicate components. Additionally, the All-Poly Tibias have undergone LAL testing and are in compliance with 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.