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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Device Description

The Klassic Femur, Porous and the Klassic® Tibial Baseplate, Porous, are being introduced as line extensions for use with the Klassic® Knee System for uncemented implantation during total knee arthroplasty. The Klassic® Femur, Porous is manufactured from Cobalt-Chromium-Molybdenum alloy and features a cobalt chrome porous sintered coating for uncemented biologic fixation. The Klassic® Tibial Baseplate, Porous is manufactured from Titanium alloy and features a titanium porous sintered coating for uncemented biologic fixation.

AI/ML Overview

This document is a 510(k) premarket notification for the Klassic® Femur, Porous and Klassic® Tibial Baseplate, Porous, knee prosthetic components. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than providing details of a clinical study with acceptance criteria and device performance as typically seen for AI/Software as a Medical Device (SaMD) products.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or available within this type of regulatory submission. This submission primarily relies on engineering analyses and non-clinical testing to demonstrate equivalence in terms of material, design, and function.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense for this submission. This document describes a new version of an existing medical device (knee implant components) and aims to prove its substantial equivalence to predicate devices, not to report performance against specific clinical acceptance criteria in a clinical trial. The "performance" here refers to mechanical and material properties.

Acceptance Criteria (Implied from testing)	Reported Device Performance (Summary of results)
Tibial-Femoral Stability Characteristics	Evaluated and deemed substantially equivalent
Stress Distributions and Range of Motion	Evaluated and deemed substantially equivalent
Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution	Evaluated and deemed substantially equivalent
Tibial Modular Disassembly Characteristics	Evaluated and deemed substantially equivalent
Adherence to ASTM F1800	Compliant
Adherence to FDA Guidance (1994)	Compliant
LAL testing requirements	Compliant

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission does not involve human clinical "test sets" or patient data in the typical sense. The testing performed is non-clinical (engineering analyses and material testing) on the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No experts were used to establish ground truth from patient data for this submission. The "ground truth" for mechanical testing is established by engineering standards and validated testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No human adjudication was involved as this is not a study assessing diagnostic accuracy or clinical outcomes based on human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This document is not for an AI/SaMD product. No MRMC studies were conducted.

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

Not Applicable. This document is not for an AI/SaMD product. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" (or basis of comparison) for the mechanical and material testing is established by validated engineering standards (e.g., ASTM F1800) and FDA guidance documents for orthopedic implants, in comparison to the performance of predicate devices.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth establishment for this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

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

October 27, 2016

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

Re: K162256

Trade/Device Name: Klassic® Femur, Porous; Klassic® Tibial Baseplate, Porous Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: August 26, 2016 Received: August 29, 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,

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) K162256

Device Name

Klassic® Femur, Porous, Klassic® Tibial Baseplate, Porous

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

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Type of Use (Select one or both, as applicable)
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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 10, 2016
Device Trade Name:	Klassic® Femur, PorousKlassic® Tibial Baseplate, Porous
Device Common Name:	Total knee replacement system
Classification:	21 CFR §888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesisClass II
Product Code:	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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

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Device Description:

Predicate Devices:

The Klassic Femur, Porous is substantially equivalent to the predicate Klassic® Knee System Femur (K112906) with respect to material, design, and function. The Klassic® Femur, Porous is substantially equivalent to the Exactech® Optetrak One Logic Porous Femoral Component (K153776) and the Wright Medical Advance® Total Knee System porous coated Femoral Components (K061223) with regards to material, function and indications for use without bone cement.

The Klassic® Tibial Baseplate, Porous is substantially equivalent to the predicate Klassic Knee System Tibial Baseplate (K112906) with respect to material, design, and function. The Klassic Tibial Baseplate, Porous is substantially equivalent to the Howmedica Osteonics Corp. Triathlon® Tritanium Tibial Baseplates (K123486) and the Wright Medical Advance Total Knee System porous coated Tibial Component (K061223) with regards to material, function and indications for use without bone cement.

Substantial Equivalence:

Engineering analyses were performed on the Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous to evaluate the Tibial-Femoral Stability Characteristics, Stress Distributions and Range of Motion, and Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution, and Tibial Modular Disassembly Characteristics. Non-Clinical testing was performed per ASTM F1800 and per the FDA Guidance Document "Guidance document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement" dated April 28, 1994. The results of analysis and testing demonstrate that the subject Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous, are substantially equivalent to the predicate devices. Additionally, the Klassic® Femur, Porous and the Klassic® Tibial Baseplate, Porous are in compliance with LAL testing requirements for orthopedic implants.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.