(131 days)
Not Found
No
The 510(k) summary describes a traditional knee implant system and wear testing, with no mention of AI or ML technology.
Yes.
The device is a total knee replacement system intended to treat conditions like rheumatoid arthritis and osteoarthritis, which are medical conditions, making it a therapeutic device.
No
The device description clearly states it is a "total knee implant device" and an "in vitro wear claims for the Smith & Nephew, Inc. Legion Primary Knee System." Its purpose is to replace knee components, not to diagnose a condition.
No
The device description clearly states it is a "Legion Primary Knee System" consisting of "total knee implant devices," which are physical components, not software. The 510(k) is for wear claims related to these physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various forms of arthritis and failed knee replacements. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a total knee implant system consisting of femoral components and articular inserts. This is consistent with a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (blood, tissue, etc.), or provide information about a patient's health status through in vitro testing. The "in vitro wear claims" refer to laboratory testing of the device's durability, not a diagnostic test performed on a patient sample.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Legion Primary Knee components are indicated for use only with cement and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
Subject of this Traditional 510(k) Premarket Notification is a request for long-term in vitro wear claims for the Smith & Nephew, Inc. Legion Primary Knee System. The wear claims will be made for the use of a Legion Primary Oxinium femoral component coupled with a 7.5 Mrad cross-linked polyethylene (XLPE) articular insert. The Legion Primary Knee System consists of existing total knee implant devices, and it is important to note that there are no new total knee components being introduced as a result of this Traditional 510(k) premarket notification.
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
Older patients
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)
In vitro knee simulator wear testing provided in the submission demonstrated that the OXINIUM®/XLPE bearing couple exhibited low wear characteristics in long-term laboratory testing as compared to a control total knee system. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance.
Clinical data was not needed to support the safety and effectiveness of the subject device.
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
Summary of Safety and Effectiveness VERILAST® Wear Claims for the LEGION* Primary Knee System Smith & Nephew, Inc.
Contact Person and Address
Jason Sells Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T (901) 399-5520
Date of Summary: April 14, 2010
4/14/2010
Name of Device: LEGION® Primary Knee System
Common Name: Total Knee Prosthesis
Device Classification Name and Reference: 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Device Class: Class II
Panel Code: Orthopaedics/87 JWH
Predicate Devices: Genesis II & Profix Zirconium Femoral Knee Components (K962557); and Crosslinked Polyethylene Articular Inserts (K071071)
Device Description
Subject of this Traditional 510(k) Premarket Notification is a request for long-term in vitro wear claims for the Smith & Nephew, Inc. Legion Primary Knee System. The wear claims will be made for the use of a Legion Primary Oxinium femoral component coupled with a 7.5 Mrad cross-linked polyethylene (XLPE) articular insert. The Legion Primary Knee System consists of existing total knee implant devices, and it is important to note that there are no new total knee components being introduced as a result of this Traditional 510(k) premarket notification.
Intended Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Legion Primary Knee components are indicated for use only with cement and are single use devices.
Performance Data
In vitro knee simulator wear testing provided in the submission demonstrated that the OXINIUM?/XLPE bearing couple exhibited low wear characteristics in long-term laboratory testing as compared to a control total knee system. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance.
Clinical data was not needed to support the safety and effectiveness of the subject device.
1
Substantial Equivalence Information
The Legion Primary Knee System consists of existing total knee implants currently marketed by Smith & Nephew. The femoral implant components are substantially equivalent to the Genesis II Oxinium femoral components cleared via K962557. The following, minor modifications were made to the Genesis II Oxinium femoral components in order to develop the subject devices:
- l Increased the thickness of the medial posterior condyle to match that of the lateral posterior condyle
- Addition of threaded screw holes for wedge attachment (posterior stabilized design only) I
- Addition of anterior wall to femoral box geometry (posterior stabilized design only) ■
- 트 Increased in height of femoral box geometry (posterior stabilized design only)
The subject femoral components are used with existing Legion articular inserts' cleared via K071071.
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for long-term wear claims for the Smith & Nephew, Inc. Legion Primary Knee System. As no new total knee components are being introduced as a result of this premarket notification, the devices are substantially equivalent to knee components currently marketed under K962557 and K071071.
1 The Genesis II cross-linked polyethylene IXLPE) articular inserts cleared via K071071 are marketed by Smith & Nephew under the Legion brand name.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 4 2010
Smith & Nephew, Inc. % Mr. Jason Sells 1450 E Brooks Road Memphis. Tennessee 38116
Re: K093746
Trade/Device Name: LEGION Primary Knee System
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: April 8, 2010 Received: April 9, 2010
Dear Mr. Sells:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Jason Sells
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbara Brem
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known). K093746
Device Name: LEGION® Primary Knee System
Indications for Use:
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Legion Primary Knee components are indicated for use only with cement and are single use devices.
Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED]
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anita for MXM
bedic. and Rest
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510(k) Number K093746