Klassic Knee System-Sombrero Patella

• K Number: K150105
• Device Name: Klassic Knee System-Sombrero Patella
• Manufacturer: TOTAL JOINT ORTHOPEDICS, INC.
• Date Cleared: 2015-02-17 ( 28 days)
• Product Code: JWH
• Regulation Number: 888.3560
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K112906 , K934695
• Predicate For: K162422 , K180159 , K183596 , K190280

Intended 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

Device Description

The Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "Klassic Knee System," specifically discussing the Sombrero Patella component. 510(k) submissions don't typically include a study of device performance against acceptance criteria in the way a clinical trial or AI/software validation would. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training sets) are not applicable to the information provided in this 510(k) summary.

However, I can extract the information relevant to the preclinical testing and the determination of substantial equivalence.

Here's a breakdown of the available information in the requested format, with an emphasis on what is and isn't applicable for a 510(k) submission of this type:

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1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category / Test	Specific Criteria Acknowledged (Implicit)	Reported Device Performance (Summary)
Premarket Acceptance	Substantial Equivalence to Predicate	Determined to be Substantially Equivalent to predicate devices.
Preclinical Testing	Comparable Contact Stress	Engineering analyses indicated comparable contact stress to predicate devices.
	Comparable Mechanical Strength	Engineering analyses indicated comparable mechanical strength to predicate devices.
Material	Ultrahigh Molecular Weight Polyethylene	Manufactured from ultrahigh molecular weight polyethylene, same material as predicate.
Geometry	Similar Dimensions & Design	Explicitly stated as substantially equivalent to predicate in geometry.
Method of Fixation	Similar Fixation Mechanism	Explicitly stated as substantially equivalent to predicate in method of fixation.

2. Sample Size used for the test set and the data provenance

• Not Applicable in the traditional sense of a clinical or performance study. This is a 510(k) submission relying on preclinical engineering analyses and comparison to predicate devices, not a test set of patient data.
• The "test set" here would refer to the designs and materials of the Sombrero Patella and the predicate devices being physically and/or computationally analyzed. The document doesn't specify a numerical "sample size" for these analyses.
• Data Provenance: The analyses were performed internally by the manufacturer (TJO - Total Joint Orthopedics). This is preclinical, in-house engineering data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. The "ground truth" for a 510(k) of this nature is substantial equivalence to a predicate device based on material, design, and performance characteristics (evaluated through engineering analyses, not expert consensus on patient outcomes). The experts involved would be the engineers and regulatory professionals conducting the analyses and preparing the submission. No external panel of clinical experts is described for determining a "ground truth" for a test set.

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

• Not Applicable. Adjudication methods are typically used in clinical trials or studies with human readers/raters where a consensus or tie-breaking mechanism is needed. This submission focuses on engineering analysis.

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 is a mechanical knee implant, not an AI/software device. MRMC studies are completely irrelevant in this context.

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

• Not Applicable. This is a mechanical knee implant, not an algorithm or software. Standalone performance as described is irrelevant.

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

• The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices (Klassic Knee Domed Patella (K112906) and Zimmer Natural Knee All Polyethylene Patella (K934695)). The new device is considered "substantially equivalent" if it meets similar performance characteristics as demonstrated by engineering analyses. There is no mention of pathology or clinical outcomes data for this specific submission for the Sombrero Patella.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a 510(k) mechanical device submission. This concept applies to machine learning algorithms.

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

• Not Applicable. As there is no training set, this question is not relevant.

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Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or justification for the Klassic Knee System's Sombrero Patella component meeting acceptance criteria is primarily a demonstration of substantial equivalence to two legally marketed predicate devices: the Klassic Knee Domed Patella (K112906) and the Zimmer Natural Knee All Polyethylene Patella (K934695).

This demonstration was achieved through preclinical engineering analyses. These analyses directly compared the Sombrero Patella to the previously cleared TJO Domed Patella in terms of:

• Contact stress
• Mechanical strength

The submission also asserts substantial equivalence based on similarities in:

• Intended use
• Material (ultrahigh molecular weight polyethylene)
• Geometry
• Method of fixation

The conclusion drawn from these analyses and comparisons (which are summarized in a "Design Control Activities Summary" not provided in full) was that "the Sombrero Patella met the pre-determined acceptance criteria for the verification activities" and is "substantially equivalent to the predicate devices." The FDA's review of this submission resulted in a determination of substantial equivalence, allowing the device to be marketed.

Summary

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

February 17, 2015

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

Re: K150105

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: January 19, 2015 Received: January 20, 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

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Page 2 - Mr. Chris Weaber

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] 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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4. Indications for Use

510(k) Number (if known): K150105

Device Name: Klassic Knee System

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

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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1. 510(k) Summary

Device Trade Name:	Klassic™ Knee System
Manufacturer:	Total Joint Orthopedics, Inc.1567 E. Stratford AvenueSalt Lake City, UT 84106
Contact:	Mr. Chris WeaberManufacturing Development Engineer1567 East Stratford Ave.Salt Lake City, Utah 84106Phone: [phone]Fax: [phone]
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: [phone]Fax: [phone]
Date Prepared:	January 19, 2015
Classification:	21 CFR 888.3560, Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis
Class:	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:

The Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.

Predicate Devices:

The Sombrero Patella is substantially equivalent to the primary predicate Klassic Knee Domed Patella (K112906) with respect to its intended use, material, geometry, and method of fixation. The Sombrero Patella is also substantially equivalent to the Zimmer Natural Knee All Polyethylene Patella (K934695) with respect to intended use, geometry and method of fixation. The information summarized in the Design Control Activities Summary demonstrates that the Sombrero Patella met the pre-determined acceptance criteria for the verification activities.

Preclinical Testing:

Engineering analyses were performed on the TIO Sombrero Patella and the previously cleared TJO Domed Patella to evaluate their contact stress and mechanical strength. The results of these analyses indicate that the Sombrero Patella is substantially equivalent to the predicate devices.

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.