The ANTHEM CR Total Knee System is a cruciate retaining implant design that includes CoCr femoral components and titanium tibia baseplate components, each available in multiple sizes; femorals: sizes 3 – 8 standard and 1 – 6 narrow with right and left options; tibia baseplates: size 1 – 8 with right and left options. The narrow femoral options have a slightly narrower ML width of the posterior condyles than the standard options of the same size. Additionally, a range of Genesis II CR Deep Flex Inserts (sizes 1-8; thicknesses 9-18mm - K041825) have been rebranded as Anthem CR HF Inserts to provide consistency within the total knee system. Both the Genesis II CR HF and Anthem CR HF branded inserts will remain on the market simultaneously with identical component designs. These inserts are singleuse prescription devices made of ultra-high molecular weight polyethylene (UHWMPE, ASTM F648) and sterilized via ethylene oxide (ETO). The existing GENESIS II Patellas (sizes: 26 – 35mm; K951987) and ANTHEM Tibia Baseplates (K142807) are used in conjunction with the new femoral to complete the ANTHEM CR Total Knee System. The GENESIS II CR Deep Flexion Inserts (sizes: 1-8; thickness: 11-30mm; K041825) in conjunction with the GENESIS II Tibia baseplate (sizes: 1-8 with left and right options; K951987) can also be substituted in the ANTHEM CR Total Knee System.

AI/ML Overview

The provided document is a 510(k) summary for the "ANTHEM® CR Total Knee System." It details the device's characteristics and its proposed equivalence to existing predicate devices. However, this document does not describe an AI or software as a medical device (SaMD), but rather a physical medical device (a knee prosthesis).

Therefore, I cannot extract information related to acceptance criteria or studies proving compliance for an AI-powered device, as the content is about a traditional orthopedic implant. The questions you've asked (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set) are relevant to AI/SaMD and are not covered in this type of 510(k) submission for a physical implant.

In summary, there is no information in the provided text to fulfill your request for an AI/SaMD acceptance criteria and study description.

Summary

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May 11, 2017

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

Smith & Nephew, Inc. Thomas Fearnley Regulatory Affairs Specialist 7135 Goodlett Farms Parkwav Cordova, Tennessee 38016

Re: K170648

Trade/Device Name: Anthem CR Total 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: March 2, 2017 Received: March 3, 2017

Dear Mr. Fearnley:

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

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with a flowing, wing-like shape above them.

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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 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" (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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K170648 - Page 1 of 1

	DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
	Food and Drug Administration	Expiration Date: January 31, 2017
	Indications for Use	See PRA Statement below.
510(k) Number (if known)	K170648
Device Name	ANTHEM TM CR Total Knee System
Indications for Use (Describe)	1. Rheumatoid arthritis.
	2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
	3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

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510(k) Summary Smith & Nephew, Inc. ANTHEM® CR Total Knee System

Submitted by:	Smith & Nephew, Inc.1450 East Brooks RoadMemphis, TN 38116
Date of Summary:	03/02/2017
Contact Person and Address:	Thomas FearnleyRegulatory Affairs SpecialistT (901) 399-6139F (901) 721-2421
Name of Device:	Smith & Nephew, Inc. ANTHEM ° CR Total Knee System
Common Name:	Knee Prosthesis
Device Classification Nameand Reference:	21 CFR 888.3560 Knee Joint Patellofemorotibiapolymer/metal/polymer semi-constrained cemented prosthesis
Device Class:	Class II
Panel Code:	Orthopedics/87
Product Code:	JWH

Device Description

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The new femoral components of the ANTHEM CR Total Knee System leverage established marketed designs (LEGION Narrow – K112941; GENESIS II – K951987) with some changes to accommodate varied patient anatomy. All of the implants are either gamma or ETO sterilized single-use prescription devices intended to be used under the guidance of a physician at a healthcare facility.

Intended Use

The Smith & Nephew ANTHEM CR Total Knee System is intended for total knee arthroplasty.

Indications for Use

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.

Technological Characteristics

Device comparisons described in this premarket notification demonstrate that the proposed femoral components and articular inserts of the ANTHEM CR Total Knee System are substantially equivalent to the legally marketed predicate devices (listed below in Table 1) with regard to intended use, indications for use, and performance characteristics. The primary technological differences that exist between the subject and predicate devices are the following:

Narrower ML width of the femoral component
Narrower anterior flange shape of the femoral component

Manufacturer	Description	Submission Number	Clearance Date
Smith & Nephew, Inc.	ANTHEM PS Knee System	K142807	12/22/2014
Smith & Nephew, Inc.	Legion Narrow CR Knee System	K112941	12/20/2011
Smith & Nephew, Inc	Genesis II CR Deep Flexion Insert	K041825	03/11/2005
Smith & Nephew, Inc.	Genesis II Total Knee System	K951987	08/22/1995

Table 1: Substantially Equivalent Predicates to the ANTHEM Total Knee System

Summary of Preclinical Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the proposed femoral and articular insert components of the ANTHEM Total Knee System. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 1. The specific types of non-clinical testing conducted are listed below and conform to the requirements of FDA Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses, dated April 1993:

Contact area testing according to ASTM F2083
Constraint testing according to ASTM F2083 and ASTM F1223 ●

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Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

Conclusion

Based on the similarities to the predicate components and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices listed in Table 1.

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.