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.

Device Description

The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.

AI/ML Overview

This document is a 510(k) premarket notification for the "Consensus Knee System Modular Tibial Baseplate." It demonstrates the device's substantial equivalence to previously marketed devices rather than providing a study demonstrating the device meets a set of acceptance criteria in the typical sense of a clinical trial for an AI/CAD product.

Therefore, the requested information elements related to AI/CAD system performance (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this regulatory submission.

However, I can extract the closest analogous information regarding the evaluation of this medical device.

1. A table of Acceptance Criteria and the Reported Device Performance:

The document describes non-clinical performance data (bench testing) to verify the device's safety and effectiveness. The "acceptance criteria" are implied by the standards used for testing (ASTM F1800-12) and the stated objective to ensure no failure or involuntary dislocation.

Acceptance Criteria (Implied)	Reported Device Performance
Baseplate Tray Region: No failure under fatigue when fully supported by its lateral compartment (per ASTM F1800-12).	Tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when fully supported by its lateral compartment. (Specific results like load cycles or maximum load are not provided in this summary, but the general statement implies successful testing.)
Keel and Taper Connection: No failure under fatigue when fully supported by an intramedullary stem (per ASTM F1800-12).	Tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. (Specific results not provided, but implies successful testing.)
Distal Plug Dislocation: Resists involuntary dislocation from the keel.	Tested to ensure it would resist involuntary dislocation from the keel. (Implies successful resistance.)
Distal Plug Insertion/Extraction: Manual insertion and extraction possible in the operating room using available instrumentation.	Tested to ensure it could be manually inserted and extracted in the operating room using available instrumentation. (Implies successful functionality.)

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

Sample Size: Not specified in terms of clinical cases or patient data, as this is bench testing. For bench testing, "sample size" would refer to the number of device components tested, which is not detailed in this summary.
Data Provenance: Non-clinical bench testing. The country of origin of testing is not specified, but the device is manufactured by a US-based company (Consensus Orthopedics, Inc., El Dorado Hills, California).
Retrospective/Prospective: Not applicable. This is non-clinical bench testing.

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. Ground truth in this context refers to the physical properties and performance of the device component itself, evaluated through engineering tests, not interpretation by medical experts.

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

Not applicable. This refers to the adjudication of clinical outcomes or diagnostic interpretations, not bench testing results.

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 conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

The "ground truth" for this device's evaluation is derived from engineering specifications and the established performance standards of ASTM F1800-12 for fatigue testing, as well as functional testing for the distal plug's retention and operability.

8. The sample size for the training set:

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.

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

March 4, 2015

Consensus Orthopedics, Incorporated Mr. Matthew M. Hull Senior Director, QS & RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

Re: K143725

Trade/Device Name: Consensus Knee System Modular Tibial Baseplate 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: January 6, 2015 Received: January 7, 2015

Dear Mr. Hull:

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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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (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 vours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K143725

Device Name: Consensus Knee System Modular Tibial Baseplate

Indications for Use:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system 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.

X Prescription Use (21 CFR Part 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR Part 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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2. 510(k) SUMMARY

Sponsor Name:	Consensus Orthopedics, Inc.1115 Windfield Way, Suite 100El Dorado Hills, CA 95762
510(k) Contact:	Matthew M. Hull, RACPhone: (916) 355-7156/ Fax: (916) 355-7190mhull@consensusortho.com
Date Prepared:	23 December 2014
Trade Name:	Consensus Knee System Modular Tibial Baseplate
Common Name:	Modular Tibial Baseplate
Classification Name:	Knee joint patellofemorotibial Polymer/metal/polymer semi-constrained cemented prosthesis is a Class 2 device per 21 CFR888.3560 (Product Code JWH/OIY)

Device Description:

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Indications for Use:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system 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.

Substantial Equivalence:

Technological Characteristics/ Substantial Equivalence:

The CKS modular baseplate is substantially equivalent to the CKS uncoated CoCr baseplate (K945589, K001456; K110950), the Consensus RKS CoCr baseplate (K100542), and the Natural-Knee II cemented modular baseplate (K023528) regarding its indications for use, technology, and performance. The distal plug used with the CKS modular baseplate, is substantially equivalent to the taper plug used with the NexGen stemmed tibial baseplate (K933785). As with the CKS modular baseplate, all predicate baseplate components are intended for cemented use.

Non-Clinical Performance Data:

Bench testing was carried out on the CKS modular baseplate and distal plug 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 fully supported by its lateral compartment. The keel and its taper connection were tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. The distal plug was tested to ensure that it would resist involuntary dislocation from the keel and to ensure that it could be manually inserted and extracted in the operating room using available instrumentation.

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.