(195 days)
Not Found
No
The description focuses on the mechanical components and materials of the knee system, with no mention of AI or ML capabilities.
Yes
The document describes a total knee replacement system intended for total knee arthroplasty to address various severe joint conditions such as arthritis and necrosis, which are therapeutic interventions.
No
The device is a knee replacement system intended for cemented use in total knee arthroplasty, which is a therapeutic intervention, not a diagnostic tool.
No
The device description clearly outlines physical components (femoral, patellar, and tibial components, polyethylene inserts) which are hardware, not software.
Based on the provided information, the Evolis Total Knee System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for cemented use in total knee arthroplasty. This is a surgical procedure performed on a patient's body to replace a damaged knee joint.
- Device Description: The description details the components of a knee prosthesis (femoral, patellar, and tibial components, articular inserts). These are implantable devices used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (in glass, or outside the living organism) to analyze samples. The Evolis Total Knee System is an in vivo device, used in vivo (in the living organism) as a surgical implant.
N/A
Intended Use / Indications for Use
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle
- post traumatic loss of joint configuration
- primary implantation failure.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Evolis Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultrahigh molecular weight polyethylene articular inserts. The femoral components are offered in left and right sizes in a standard and a posterior stabilized design of six sizes. The tibial baseplates are offered in six sizes. The tibial inserts are offered in three styles: standard, posterior-stabilized and ultra-congruent. Each of the three styles is offered in six sizes, corresponding to the tibial base plate sizes, in five thicknesses from 9 -19 mm each. The patellar components are offered in two options: an inset patella and a resurfacing patella. The inset patella is offered in the three sizes and the resurfacing patella is offered in four sizes. The femoral components and the tibial base plates are offered in coated options with a plasma spray titanium coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing of the Evolis Total Knee System was conducted in accordance with various international standards and FDA guidance documents.
The Evolis Total Knee System was tested as part of design verification to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the above standards and guidance. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that performance of the Evolis Total Knee System is substantially equivalent to the predicate devices.
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.
K072281, K072619, K070981, K060722, K031061, K991581, K963148, K960279, K951185
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 a handwritten number 3. The number is written in a simple, slightly curved style. The background is plain white, which makes the number stand out clearly.
Image /page/0/Picture/2 description: The image shows the logo for Medacta International. The logo consists of two black triangles pointing upwards, followed by the word "Medacta" in black sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, and to the right of the word is a symbol that looks like a plus sign.
OCT 22 2008
510(k) Summary
Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX
Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@nikconsulting.com
Date Prepared: July 7, 2008
DEVICE INFORMATION
Trade/Proprietary Name: Evolis Total Knee System Common Name Total Knee Prosthesis Classification Name: Knee joint patellofemorotibial metal/polymer/metal semiconstrained cemented prosthesis, 21 CFR 888.3560, product code JWH
Predicate Devices:
K072281, NexGen® Prolong All-Poly Patella;
K072619, NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component:
K070981, Search Evolution (LC) Total Knee System,
K060722, NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component;
K031061, NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components:
K991581, NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS), LPS-Flex Fixed Bearing Femoral and Articular Surface Components;
Evolis Total Knee System 510(k)
Section 5 - Page 2 of 4
1
LOSIVE + Holla
K963148. NexGen® Complete Knee Solution Fluted Stemmed Tibial Component.
K960279, NexGen® Legacy PS (L-PS) and NexGen® CCK (L-CCK) K951185, NexGen® Total Knee Solution 9 mm Tibial Articular Surface
Product Description:
The Evolis Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultrahigh molecular weight polyethylene articular inserts. The femoral components are offered in left and right sizes in a standard and a posterior stabilized design of six sizes. The tibial baseplates are offered in six sizes. The tibial inserts are offered in three styles: standard, posterior-stabilized and ultra-congruent. Each of the three styles is offered in six sizes, corresponding to the tibial base plate sizes, in five thicknesses from 9 -19 mm each. The patellar components are offered in two options: an inset patella and a resurfacing patella. The inset patella is offered in the three sizes and the resurfacing patella is offered in four sizes. The femoral components and the tibial base plates are offered in coated options with a plasma spray titanium coating.
Indications for Use:
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- . avascular necrosis of femoral condyle
- . post traumatic loss of joint configuration
- primary implantation failure, .
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food. Drug and Cosmetic Act. Performance testing of the Evolis Total Knee System was conducted in accordance with various international standards and FDA guidance documents.
The Evolis Total Knee System was tested as part of design verification to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the above standards and guidance. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that performance of the Evolis Total Knee System is substantially equivalent to the predicate devices.
Evolis Total Knee System 510(k)
Section 5 - Page 3 of 4
2
KCC245 #517
Conclusion:
The data and information provided in this submission support the conclusion that the Evolis Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
Evolis Total Knee System 510(k)
.
: ・
Section 5 - Page 4 of 4
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a circular shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top and left side of the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDACTA International SA % NJK & Associates, Inc. Ms. Natalie J. Kennel 13721 Via Tres Vista San Diego, California 92129
OCT 22 2008
Re: K081023 Trade/Device Name: Evolis Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 13, 2008 Received: October 15, 2008
Dear Ms. Kennel:
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
4
Page 2 – Ms. Natalie J. Kennel
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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mikkelson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K081023
Device Name: Evolis Total Knee System
Indications for Use:
The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- . avascular necrosis of femoral condyle
- post traumatic loss of joint configuration .
- primary implantation failure. .
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle for XM
ivision Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K081023
of