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

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 expand the size offerings of the Klassic® Knee System to include a Size 7 femoral component. These components are manufactured from Cobalt-Chromium Alloy.

AI/ML Overview

This document is a 510(k) premarket notification for the Klassic® Knee System. It is primarily concerned with establishing substantial equivalence of an expanded size offering (Size 7 femoral component) to a previously cleared version of the same device. Therefore, it does not contain the detailed clinical study information typically provided for novel devices or AI/software-as-a-medical-device (SaMD) clearances.

Based on the provided text, here's what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from text)	Reported Device Performance (from text)
Not explicitly stated as acceptance criteria, but implied tests:	The information summarized in the Design Control Activities Summary demonstrates that the Klassic Knee Femur, Size 7, met the pre-determined acceptance criteria for the verification activities.
	Results of engineering analyses indicate that the Size 7 Klassic Knee Femurs are substantially equivalent to the predicate components in terms of:
Tibial-Femoral Instability and Contact Stress	Substantially equivalent to predicate.
Patella-Femoral Instability and Contact Stress	Substantially equivalent to predicate.

Note: The document references "pre-determined acceptance criteria for the verification activities" but does not explicitly list what those criteria were (e.g., specific stress limits, acceptable range of motion, wear rates, etc.) or the detailed quantitative results for each.

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

Not Applicable. This document describes a modification to a medical device (a knee implant) primarily based on engineering analyses rather than clinical study data involving patients. No "test set" of patient data is mentioned. The assessment is based on comparing the new size to existing sizes through engineering principles.

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

Not Applicable. As above, no patient-based clinical "test set" requiring expert ground truth establishment is described. The evaluation is based on engineering analyses.

4. Adjudication Method for the Test Set:

Not Applicable. No human adjudication of a clinical test set is relevant to this type of device modification submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document does not describe an MRMC study. Such studies are typically for evaluating diagnostic imaging or AI-assisted diagnostic tools, not for a physical implant modification directly.

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

Not Applicable. This device is a physical knee implant, not an algorithm or software.

7. The Type of Ground Truth Used:

Engineering principles and predicate device data. The "ground truth" for demonstrating substantial equivalence of the new femoral component size is rooted in established engineering analysis methods, material properties, and the performance characteristics of the previously cleared predicate Klassic® Knee System components.

8. The Sample Size for the Training Set:

Not Applicable. This document does not describe a machine learning algorithm or an AI model, and therefore, there is no "training set" in this context.

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

Not Applicable. See point 8.

In summary: This document is focused on demonstrating the substantial equivalence of a new size of a previously cleared knee implant through engineering analyses and comparison to a predicate device, rather than through a clinical study with patient data or an evaluation of an AI algorithm's performance. Therefore, many of the requested data points related to clinical efficacy, expert review, and AI model evaluation are not applicable or present in this specific regulatory submission.

Summary

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

December 17, 2015

Total Joint Orthopedics, Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106

Re: K153310 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: November 16, 2015 Received: November 17, 2015

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 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/Resourcesfor You/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 yours,

Mark N. Melkerson -S

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) K153310

Device Name Klassic® Knee System

Indications for Use (Describe)

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

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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5. 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 WeaberManufacturing Development Engineer
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: 202.552.5800Fax: 202.552.5798
Date Prepared:	November 16, 2015
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 cemented
	Class II
Product Code:	JWH

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): o 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) with respect to indications, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the Klassic Knee Femur, Size 7, met the pre-determined acceptance criteria for the verification activities.

Substantial Equivalence:

Engineering analyses were performed on the Klassic Knee Femur, Size 7, and the previously cleared femurs to evaluate the Tibial-Femoral Instability and Contact Stress and Patella-Femoral Instability and Contact Stress. The results of these analyses indicate that the Size 7 Klassic Knee Femurs are substantially equivalent to the predicate components.

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.