(61 days)
Not Found
Not Found
No
The summary describes a mechanical implant (femoral component for total knee replacement) and its intended use and mechanical testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typical indicators of AI/ML technology in medical devices.
No
The device is a knee implant designed to replace part of the knee joint in patients with various forms of arthritis, which is a structural intervention rather than a device for therapy.
No
Explanation: The device is a Total Knee Femoral Component, an implant designed for replacement procedures, not for diagnosing conditions.
No
The device description clearly states it is a metal alloy device, indicating it is a physical hardware component, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Total Knee Femoral Component, which is a surgical implant used in total knee replacement surgery. It is a physical device implanted into the body.
- Intended Use: The intended use clearly states it's for treating various forms of arthritis and failed previous surgeries, all of which are conditions requiring surgical intervention and replacement of the joint.
The description focuses on the physical characteristics, intended surgical use, and mechanical performance of the implant, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic arthritis; degenerative arthritis; failed osteotomies; hemiarthroplasties, unicompartmental replacement; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.
Product codes
JWH
Device Description
The Total Knee Femoral Components are designed for use with tibial and patellar components of the Genesis II or Profix Total Knee Systems. The Total Knee Femoral Components are metal alloy devices processed via a proprietary oxidation process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (implied by "Total Knee" and "knee joint patellofemorotibial")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical and Clinical Data: A review of the mechanical test data indicated that the Total Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Wear Claims:
- " {Total Knee Femoral Components} offer an 85% reduction in aggregate wear rate as compared to cobalt chrome (CoCr) femoral components (0.69 + 0.52 mm3/million cycles vs. 4.68 ± 2.30 mm /million cycles). Testing was performed in a multi-axial knee joint simulator for a minimum of 6 million cycles per individual test using size 5 Genesis II femoral components as an articulating counterface, size 5 Genesis II UHMWPE tibial inserts, and Hyclone bovine calf serum as a lubricant. UHMWPE tibial inserts were sterilized via ethylene oxide. For each test condition the aggregate wear rates were computed as the slope of the line fit through the averaged data (n=3) after the initial wear-in period of 1.94 million cycles (1.e., 1.94 -- 6.13 million cycles). The results of invitro tests have not been shown to correlate with clinical wear mechanisms."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"85% reduction in aggregate wear rate as compared to cobalt chrome (CoCr) femoral components (0.69 + 0.52 mm3/million cycles vs. 4.68 ± 2.30 mm /million cycles)."
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.
Not Found
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.
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AUG 1 9 2002
Kodd2010
page 1 of 2
Summary of Safety and Effectiveness Smith & Nephew, Inc. Total Knee Femoral Component
Contact Person and Address
Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
The Total Knee Femoral Components are designed for use with tibial and patellar components of the Genesis II or Profix Total Knee Systems. The Total Knee Femoral Components are metal alloy devices processed via a proprietary oxidation process.
Device Classification Name
21 CFR 888.3560 Knee joint patellofemorotibial metal/polymer/metal semi-constrained cemented prosthesis - Class II
Indications for Use
The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic arthritis; degenerative arthritis; failed osteotomies; hemiarthroplasties, unicompartmental replacement; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the Total Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Wear Claims
The following marketing claim will be made for the Total Knee Femoral Components:
- " {Total Knee Femoral Components} offer an 85% reduction in aggregate wear rate as compared to cobalt chrome (CoCr) femoral components (0.69 + 0.52 mm3/million cycles vs. 4.68 ± 2.30 mm /million cycles). Testing was performed in a multi-axial knee joint simulator for a minimum of 6 million cycles per individual test using size 5 Genesis II femoral components as an articulating counterface, size 5 Genesis II UHMWPE tibial inserts, and Hyclone bovine calf serum as a lubricant. UHMWPE tibial inserts were sterilized via ethylene oxide. For each test condition the aggregate wear rates were computed as the slope of the line fit through the averaged data (n=3) after the initial
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wear-in period of 1.94 million cycles (1.e., 1.94 -- 6.13 million cycles). The results of invitro tests have not been shown to correlate with clinical wear mechanisms."
Substantial Equivalence Information
The substantial equivalence of the Total Knee Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components of the Genesis II and Profix Total Knee Systems distributed by Smith & Nephew, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is 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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim P. Kelly, M.S. Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Re: K022010 Trade/Device Name: Total Knee Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: July 22, 2002 Received: July 23, 20002
Dear Ms. Kelly:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
AUG 1 9 2002
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Page 2 - Ms. Kim P. Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark A. Melkus
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K022010
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Total Knee Femoral Components Indications Statement
The Total Knee Femoral Components are indicated for rheumatoid arthritis; posttraumatic athritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; or total knee arthroplasties. The Total Knee Femoral Components are single use only and are intended for implantation with bone cement.
Mark N. Millhiser
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO22010 510(k) Number _
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation
Prescription Use
OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________