(69 days)
Not Found
No
The description focuses on the physical components and materials of a total knee replacement system, with no mention of AI or ML capabilities.
Yes
The device is a medical implant intended for total knee arthroplasty, which is a procedure to restore function and alleviate symptoms in a diseased or damaged joint. This fits the definition of a therapeutic device as it treats a medical condition.
No.
The device is a total knee system, which is a prosthetic implant for knee arthroplasty, not a diagnostic tool.
No
The device description explicitly details physical components made of CoCr, titanium, and UHWMPE, indicating it is a hardware-based implant system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "total knee arthroplasty," which is a surgical procedure to replace a damaged knee joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a "cruciate retaining implant design" consisting of physical components like femoral components, tibia baseplates, and inserts. These are implantable medical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Smith & Nephew ANTHEM CR Total Knee System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew ANTHEM CR Total Knee System is intended for total knee arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician at a healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Contact area testing according to ASTM F2083 and Constraint testing according to ASTM F2083 and ASTM F1223. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K142807, K112941, K041825, K951987
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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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."
3
510(k) Summary Smith & Nephew, Inc. ANTHEM® CR Total Knee System
| Submitted by: | Smith & Nephew, Inc.
1450 East Brooks Road
Memphis, TN 38116 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date of Summary: | 03/02/2017 |
| Contact Person and Address: | Thomas Fearnley
Regulatory Affairs Specialist
T (901) 399-6139
F (901) 721-2421 |
| Name of Device: | Smith & Nephew, Inc. ANTHEM ° CR Total Knee System |
| Common Name: | Knee Prosthesis |
| Device Classification Name
and Reference: | 21 CFR 888.3560 Knee Joint Patellofemorotibia
polymer/metal/polymer semi-constrained cemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopedics/87 |
| Product Code: | JWH |
Device Description
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.
4
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
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- 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 ●
5
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.