A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

Device Description

The CKS Plus extension to the Consensus Knee System (CKS) is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw, tibial intramedullary (IM) stem fixation, and tibial augments

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "CKS Plus Knee System." It details the device, its indications for use, and claims substantial equivalence to predicate devices. Crucially, as a 510(k) summary for a medical device (a knee prosthesis), the focus is on demonstrating substantial equivalence through comparison to existing devices and bench testing, not on clinical performance studies involving AI or complex statistical analyses of diagnostic accuracy. Therefore, many of the requested elements for an AI/diagnostic device study (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of document.

The document primarily discusses non-clinical performance data (bench testing) to verify the safety and effectiveness of the CKS Plus Knee System's components, focusing on mechanical properties and stability rather than diagnostic accuracy or human interpretation.

Here's an attempt to address the request based only on the provided text, highlighting what is (and isn't) present:

A. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a formal table with reported performance side-by-side, as would be typical for a diagnostic device's clinical study. Instead, it lists the types of bench tests performed and implies that the device "meets" the requirements by stating it passed. The criteria are implicit in the ASTM standards and other specified tests.

Acceptance Criteria (Implicit from Test Standards/Purpose)	Reported Device Performance (Implied from "Testing Performed")
Adequate tray fatigue strength (per ASTM F1800-12)	"the tray would not fail under fatigue when one compartment collapses"
Tibiofemoral joint stability (per ASTM F1223-14)	Tested for PS-C insert per ASTM F1223-14
Adequate tibial insert locking mechanism strength	Tested per FDA's Class II Special Controls Guidance to ensure adequate connection strength and ease of insertion
No failure in PS Post Fatigue Testing	"PS Post Fatigue Testing, Report" (implies successful completion)
No failure in Baseplate Fatigue Testing	"Baseplate Fatigue Testing, Report" (implies successful completion)
No failure in Tibial Insert Dislocation Testing	"Tibial Insert Dislocation Testing, Report" (implies successful completion)
No failure in VitalitE PS Post Fatigue Testing	"VitalitE PS Post Fatigue Testing, Report" (implies successful completion)
No failure in Tray Fatigue (FEA Worst Case)	"Tray Fatigue: FEA Worst Case Scenario, Report" (implies successful completion)
No failure in Stem Fatigue (FEA Worst Case)	"Stem Fatigue: FEA Worst Case Scenario, Report" (implies successful completion)
Pyrogenicity absence	"Pyrogenicity testing has been performed" (implies successful completion)

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

Sample Size for Test Set: Not specified in terms of number of devices or components tested. The document mentions "bench testing" was carried out, but does not provide specific sample quantities for each test.
Data Provenance: The tests are "bench testing," meaning they are performed in a laboratory setting on components or full devices, not on human subjects. Thus, there is no country of origin for human data, nor is it retrospective or prospective in that context.

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

Experts: Not applicable. This is not a study requiring expert consensus for ground truth on diagnostic performance. The "ground truth" for mechanical testing is adherence to validated ASTM standards and engineering principles.

D. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.

E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

MRMC Study: No, an MRMC study was not done. This device is a knee prosthesis, not an AI or diagnostic tool that relies on human interpretation of cases. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

F. If a Standalone (algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical medical device (knee implant), not an algorithm or AI system.

G. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the performance claims for this device is based on engineering standards, ASTM specifications, and mechanical testing results. For example, ASTM F1800-12 defines criteria for tray fatigue, and success is determined by meeting those predefined engineering benchmarks.

H. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes the testing of a physical medical device, not the training of an AI algorithm.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are connected to a flowing, ribbon-like shape below. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

Consensus Orthopedics, Inc. Zac Johnson Regulatory Affairs Project Manager 1115 Windfield Way El Dorado Hills, California 95762

August 9, 2017

Re: K163167 Trade/Device Name: CKS Plus 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, OIY Dated: July 10, 2017 Received: July 10, 2017

Dear Zac Johnson:

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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 (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" (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 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) K163167

Device Name CKS Plus Knee System

Indications for Use (Describe)

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or

degenerative arthritis.

B. Failed osteotomy or unicompartmental replacements.

C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without

cement.

F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

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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1. 510(k) SUMMARY

Sponsor Name:	Consensus Orthopedics, Inc.1115 Windfield WayEl Dorado Hills, Ca 95762
510(k) Contact:	Name: Zac JohnsonPhone: (916) 355-7154Fax: (916) 355-7190Email: zjohnson@consensusortho.com
Date Prepared:	30 July 2017
Trade Name:	CKS Plus Knee System
Common Names	Total Knee Implant
Classification Name:	Knee joint patellofemorotibial Polymer/metal/polymer semiconstrainedcemented prosthesis is a Class 2 device per 21 CFR 888.3560 (ProductCode JWH, OIY)

Device Description:

Indications for Use:

The CKS Plus Knee System is designed to be used in conjunction with Consensus Knee System Components and is not intended for substitution of components from other systems.

The indications for use are:

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

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F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

Substantial Equivalence:

Consensus Orthopedics, Inc. (COI) asserts the CKS Plus Knee System, an extension to the Consensus Knee System (CKS) implant components to be substantially equivalent to legally marketed predicate devices regarding their indications for use, technology, and performance (Table 6.1). The Primary Predicate used the evaluation of the CKS Plus Knee System is K932837. The CKS Plus Knee System Congruent tibial insert is substantially equivalent to the CKS congruent tibial insert made from standard UHMWPE (K932837, K110950) or VitalitE (K133919). The CKS Fortified Dovetail PS tibial insert is substantially equivalent to the CKS PS tibial insert made from standard UHMWPE (K954818, K110950, K133919). The CKS Plus Knee System PS and PS-C tibial inserts are substantially equivalent to the CKS PS tibial insert made from standard UHMWPE (K954818, K110950) and the Vitamin E material used in the CKS tibial inserts made from VitalitE (K133919). The CKS Plus PCL Substituting tibial inserts are substantially equivalent to the CKS PCL Substituting tibial insert made from conventional UHMWPE (K953443, K110950) and VitalitE (K133919).

The CKS Plus cruciform tibial baseplate is substantially equivalent to the CKS tibial baseplate (K932837, K110950), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542). The CKS Plus Knee System stemmed tibial baseplate is substantially equivalent to the CKS tibial baseplate (K932837, K110950), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542). The CKS Plus tibial augments and screws are substantially equivalent to the CRKS tibial augments and screws (K100542).

All implant devices compatible with the CKS Plus Knee System extension to the Consensus Knee System are legally marketed in the US (Table 6.2). The CKS CR and RLP CR femoral components and the CRKS femoral components intended for use with the CKS Plus Knee System Congruent and PCL Substituting tibial inserts were previously cleared for use with the CKS Congruent and PCL Substituting tibial inserts (K932837, K110950, K133919, K100542). The CRKS femoral component intended for use with the CKS Plus Knee System Congruent and PCL Substituting Tibial inserts was previously cleared for use with the CKS Congruent and PCL Substituting Tibial Inserts (K100542). The CKS PS and RLP femoral components intended for use with the CKS Plus Knee System PS and PS-C tibial, as well as the CKS Fortified Dovetail PS inserts, were previously cleared for use with the CKS PS tibial insert (K954818, K110950).

The CRKS stem and CRKS taper plug intended for use with the CKS Plus Knee System stemmed baseplates were previously cleared for use with the CKS modular baseplate (K143725) and the CRKS baseplate (K100542). The 6.5mm cancellous bone screw intended for use with the CKS Plus Knee System cruciform baseplates was previously cleared for use with the CKS modular baseplate (K143725) and the CKS uncoated CoCr baseplate (K945589). The cement dam intended for use with the CKS Plus Knee System cruciform holed baseplates was previously cleared for use with the CKS modular baseplate (K143725) and the CKS uncoated CoCT

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baseplate (K945589). The augment screws intended for use with the CKS Plus 6mm tibial baseplates were previously cleared for use with the CRKS baseplate (K100542). The half wrap versions of all CKS Plus Knee System tibial baseplates are intended for use with previously cleared CKS tibial inserts (K932837, K110950, K133919, K100542).

CKS Fortified Dovetail PS and all CKS Plus Knee System Congruent, PCL Substituting, and PS tibial inserts are intended to be compatible with previously cleared CKS tibial baseplates (K932837, K945589, K001456, K110950), CKS modular baseplates (K143725) and CRKS baseplates (K945589, K100542)

Non-Clinical Performance Data:

Bench testing was carried out on CKS Plus Knee System implant components to verify their safety and effectiveness for clinical use. The baseplate tray region was tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when one compartment collapses. Tibiofemoral joint stability was tested for the PS-C insert per ASTM F1223-14. The tibial insert locking mechanism was tested per FDA's Class II Special Controls Guidance to ensure adequate connection strength and ease of insertion. Wear testing and contact pressure were not deemed necessary because the articular surfaces are identical to the predicate devices. Testing of modular junctions with all previously cleared components (i.e. IM stem, augments) was similarly not tested due to consistency of design. Pyrogenicity testing has been performed.

Testing Performed

Peel Out Testing of the Posterior Stabilized Insert : Verification of a Fortified Dovetail, Report

PS Post Fatigue Testing, Report

Baseplate Fatigue Testing, Report

Tibial Insert Dislocation Testing, Report

1223 Stability Testing, Report

VitalitE PS Post Fatigue Testing, Report

Report_CKS_Wear Sim_Tibiofem_Part Anal_VitE_Congr-RLP_Accutek_K12106826-4_101813

Tray Fatigue: FEA Worst Case Scenario, Report

Stem Fatigue: FEA Worst Case Scenario, Report

Insert Layout Analysis, Report

Range of Motion Analysis, Report

Range of Motion Analysis, Varus/Valgus Tilt,, Report

Tibial Insert Articular Surface Study, Rport

Range of Motion Analysis - Additional Sizes, Report

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.