· 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 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the product submitted in K190280:

The document (K190280) describes a 510(k) submission for new sizes of patella components (size 5, 10mm Sombrero Patella in Standard Poly and E-Link Poly) to be added to the existing Klassic® Knee System. The primary method of demonstrating substantial equivalence is through engineering analyses and comparison to predicate devices that are already cleared.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Conformance	Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits for knee prosthetic components.	"The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of conformance. This implies they meet the same or similar conformance standards as the previously cleared predicate devices (K150105 & K180159).
Contact Area	Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits for knee prosthetic components to ensure proper articulation and wear characteristics.	"The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of contact area. This implies they maintain appropriate contact area similar to the previously cleared predicate devices.
Contact Stress	Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits to prevent material degradation and ensure longevity of the implant.	"The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of contact stress. This suggests the contact stresses are within acceptable physiological and material limits, comparable to the predicate devices.
Mechanical Strength	Not explicitly detailed in the provided text as specific numerical criteria, but implied to be sufficient to withstand the physiological loads and stresses experienced in a knee joint over the expected lifespan of the implant.	"The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of mechanical strength. This implies the new components possess adequate strength comparable to the predicate devices.
Peg Geometry	Not explicitly detailed in the provided text as specific numerical criteria, but implied to be consistent with the existing Klassic Knee System to ensure proper fixation and compatibility.	"The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of peg geometry. This ensures the pegs are properly sized and shaped for intended use and fixation within the larger Klassic Knee System.
LAL Testing	Compliance with LAL (Limulus Amebocyte Lysate) testing requirements for orthopedic implants, typically to ensure absence of endotoxins. The specific acceptance criteria for LAL are standardized but not detailed here.	The subject components are in "compliance with LAL testing requirements for orthopedic implants." This indicates they passed the standard LAL test, demonstrating a safe level of endotoxins.

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

The provided text does not describe a clinical study with a "test set" in the traditional sense of patient data. Instead, it relies on engineering analyses and comparison to predicate devices. Therefore:

Sample Size for Test Set: Not applicable as it's not a clinical study with patient data. The "test set" would be the specific physical components (size 5, 10mm Sombrero Patellae) that were subjected to the engineering analyses. The number tested is not specified but would typically be one or more samples per analysis to ensure consistency.
Data Provenance: Not applicable as it's engineering analysis, not patient data from a specific country or collected retrospectively/prospectively. The analyses are performed on the device itself.

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

Number of Experts: Not applicable. For engineering analyses, "ground truth" is established through engineering principles, material science, and regulatory standards, not by expert consensus on clinical images or outcomes.
Qualifications of Experts: The analyses would be performed by qualified engineers or technicians with expertise in biomaterials, biomechanics, and medical device testing, but this is not a ground truth establishment by clinical experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no ambiguous patient data requiring adjudication. The results of the engineering analyses are typically objective measurements and calculations compared against established criteria or predicate device performance.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a medical device for knee replacement components, not an AI/imaging device.

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

Standalone Performance Study: No, this is not an AI/algorithm-driven device. It's a physical orthopedic implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" in this context refers to the established performance characteristics and safety profile of the predicate devices (size 1-4 Sombrero Patellae, K150105 & K180159), as well as established engineering and material science principles and regulatory standards for orthopedic implants. The new device components are deemed substantially equivalent if they meet these established engineering performance benchmarks or demonstrate comparable performance to the predicates.

8. The Sample Size for the Training Set

Sample Size for 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

Ground Truth for Training Set: Not applicable.

Summary

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

March 15, 2019

Re: K190280

Trade/Device Name: Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. MBH. OIY Dated: February 8, 2019 Received: February 8, 2019

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Daniel S. Ramsey -S 2019.03.15 11:38:59 -04'00'

FOR 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) K190280

Device Name Klassic® Knee System

Indications for Use (Describe)

The Klassic Knee System is intended for prosthetic replacement in treatment 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 with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. which are indicated for cementless use.

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: 801.486.6070
Contact:	Mr. Chris WeaberProduct Development, Regulatory Manager
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	February 8, 2019
Device Trade Name:	Klassic® Knee System
Device Common Name:	Polyethylene Patella Component
Classification:	21 CFR 888.3560, Knee Joint Patellofemorotibial Polymer/ metal/polymer semi-constrained cemented prosthesis21 CFR 888.3565, Knee joint patellofemorotibial polymer/ metal/polymer semi-constrained porous coated uncemented prosthesis
Class:	II
Product Codes:	JWH, MBH, OIY

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 (NIDJ): 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 3DTM, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

Device Description:

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TJO Klassic® Knee System – Special 510(k)

Predicate Devices:

The subject size 5, 10mm Sombrero Patella implants are substantially equivalent to the predicate size 1-4 Sombrero Patellae (K150105 & K180159) with respect to their intended use, material, geometry, and method of fixation. The information summarized in the Design Control Activities Summary demonstrates that the subject size 5, 10mm Sombrero Patellae met the pre-determined acceptance criteria for the verification activities.

Substantial Equivalence:

Engineering analyses were performed on the subject size 5, 10mm Sombrero Patellae to evaluate their conformance, contact area and contact stress, mechanical strength, and peg geometry. The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae. Additionally, the subject components are in compliance with LAL testing 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.