(84 days)
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a total knee system intended for total knee arthroplasty to treat conditions like arthritis and failed previous surgeries, which are therapeutic interventions.
No
Explanation: The provided text describes the ANTHEM PS Total Knee System as a total knee arthroplasty implant. It is a surgical device used for replacement, not a diagnostic tool for identifying a condition or disease.
No
The device description explicitly details physical components made of cobalt chromium and titanium, which are hardware implants for total knee arthroplasty.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "total knee arthroplasty," which is a surgical procedure to replace a damaged knee joint. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The device is described as a "posterior stabilized implant design" consisting of femoral and tibia components. These are physical implants intended to be placed within the body.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, analysis of biological samples (blood, urine, tissue), or diagnostic testing for diseases or conditions.
- Anatomical Site: The anatomical site is the "Knee joint," which is where the implant is surgically placed.
Therefore, the Smith & Nephew ANTHEM PS Total Knee System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The subject ANTHEM PS Total Knee System is a posterior stabilized implant design that includes cobalt chromium (ASTM F75) femoral components and titanium (ASTM F1472) tibia baseplate components that are intended to be used with existing GENESIS II components to complete the total knee construct. The femoral components are based on the LEGION Narrow PS (K112941) and GENESIS II PS (K951987) designs, and are available in two categories: ANTHEM Standard (Sizes: 3-8; left and right options) and ANTHEM Narrow (Sizes 1-6; left and right options). The ANTHEM Tibia Baseplates are leveraged from the GENESIS II Tibia Baseplate (K951987) design, with a modification to the stem, and provided in sizes 1-8 with left and right options. All of the implants are gamma 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 tibial components of the ANTHEM Total Knee System.
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
Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 1.
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.
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
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2014
Smith and Nephew, Incorporated % Mr. Samir Ibrahim Senior Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
Re: K142807 Trade/Device Name: ANTHEM PS Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 26, 2014 Received: September 29, 2014
Dear Mr. Ibrahim:
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
1
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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification Indications for Use Statement
510(k) Number (if known): K142807
Device Name: ANTHEM® PS Total Knee System
Indications for Use:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.
Prescription Use ______________ (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _ (Part 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)
3
510(k) Summary Smith & Nephew, Inc. ANTHEM® PS Total Knee System
| Submitted by: | Smith & Nephew, Inc.
1450 East Brooks Road
Memphis, TN 38116 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Summary: | September 26, 2014 |
| Contact Person and Address: | Samir Ibrahim, PhD, MBA, RAC
Senior Regulatory Affairs Specialist
T (901) 399-6139
F (901) 721-2421 |
| Name of Device: | Smith & Nephew, Inc. ANTHEM® PS 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 subject ANTHEM PS Total Knee System is a posterior stabilized implant design that includes cobalt chromium (ASTM F75) femoral components and titanium (ASTM F1472) tibia baseplate components that are intended to be used with existing GENESIS II components to complete the total knee construct. The femoral components are based on the LEGION Narrow PS (K112941) and GENESIS II PS (K951987) designs, and are available in two categories: ANTHEM Standard (Sizes: 3-8; left and right options) and ANTHEM Narrow (Sizes 1-6; left and right options). The ANTHEM Tibia Baseplates are leveraged from the GENESIS II Tibia Baseplate (K951987) design, with a modification to the stem, and provided in sizes 1-8 with left and right options. All of the implants are gamma 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 PS Total Knee System is intended for total knee arthroplasty.
4
Indications for Use
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the proposed femoral and tibial components of the ANTHEM PS 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
- Shorter, non-tapered stem of the tibial component ●
| . | |||
|---|---|---|---|
| Manufacturer | Description | Submission Number | Clearance Date |
| Smith & Nephew, Inc. | Legion Narrow PS Knee System | K112941 | 12/20/2011 |
| Smith & Nephew, Inc. | Genesis II PS 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 tibial 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
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.