(72 days)
Not Found
No
The document describes a knee implant and its design, materials, and intended use. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a femoral component for total knee replacement, which is a surgical procedure to alleviate pain and restore function in arthritic or damaged knees. This aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The document describes a medical implant (femoral component for a total knee replacement), not a device used to diagnose a condition.
No
The device description clearly states it is a physical femoral component made of cobalt chromium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, 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 knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral component made of cobalt chromium alloy, designed for implantation in the knee. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for:
- 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 Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral 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
Genesis II PS Non-modular and CR Non-modular with cement pocket femoral components are line extension of the Genesis II Total Knee System. It provides a non-modular option of the PS knee which is similar to the nonmodular CR knee in design concept. It is available from size 1-8 and in left and right configuration. The Nonmodular PS/CR femoral components are available with or without the feature of cement pocket. The material is cobalt chromium alloy (ASTM F75-07). The femoral component is a single use device and supplied sterile (Gamma sterilization). The Genesis II PS Non-modular with cement pocket femoral components can be implanted using the standard Genesis II Instrumentation or the Genesis II ECO Instrumentation.
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
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)
Design verification has been performed based on requirements outlined in FDA's Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses, dated April 1993. Technical report and justifications provided in the submission demonstrated that the Genesis II PS Nonmodular and CR Non-modular with cement pocket Femoral Components met performance requirements and are as safe and effective as the predicate devices.
Clinical data was not needed to support the safety and effectiveness of the subject 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.
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
510(k) Summary
Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components Smith & Nephew, Inc.
MAY 18 2012
Contact Person and Address:
Date of Summary: February 28; 2012
Xiang Zhang Director, Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-6929
Name of Device: Genesis II PS Non-modular Femoral Components; Genesis II CR Non-modular with cement pocket Femoral Components; Genesis II Select Femoral Components; Genesis II ECO Instruments Common Name: Knee Prosthesis
Device Classification Name and Reference:
Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis, 21 CFR 888.3560 Device Class: Class II.
Panel Code: Orthopaedics/87 JWH
Predicate Device: Genesis II Total Knee System, K951987
Device Description
Genesis II PS Non-modular and CR Non-modular with cement pocket femoral components are line extension of the Genesis II Total Knee System. It provides a non-modular option of the PS knee which is similar to the nonmodular CR knee in design concept. It is available from size 1-8 and in left and right configuration. The Nonmodular PS/CR femoral components are available with or without the feature of cement pocket. The material is cobalt chromium alloy (ASTM F75-07). The femoral component is a single use device and supplied sterile (Gamma sterilization). The Genesis II PS Non-modular with cement pocket femoral components can be implanted using the standard Genesis II Instrumentation or the Genesis II ECO Instrumentation.
Intended Use
The Genesis II PS Non-modular with cement pocket Femoral Components are indicated for:
- Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
Failed osteotomies, unicompartmental replacement, or total knee replacement. కి.
Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where 4. the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for use only with cement and are single use devices.
Performance Data
Design verification has been performed based on requirements outlined in FDA's Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses, dated April 1993. Technical report and justifications provided in the submission demonstrated that the Genesis II PS Nonmodular and CR Non-modular with cement pocket Femoral Components met performance requirements and are as safe and effective as the predicate devices.
1
510(k) Summary Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components Smith & Nephew, Inc.
Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The Smith & Nephew Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are similar to the following commercially available devices regarding indications and.technological characteristics:
- = Smith & Nephew Genesis II Total Knee System (K951987)
Conclusion
This Special 510(k) Premarket Notification is being submitted for new Genesis II PS Non-modular and CR Nonmodular with cement pocket Femoral Components that have been designed and developed by Smith & Nephew Inc. Given that the new devices have met all performance requirements and share the same design features, indications, and materials as the predicates, the devices can be considered substantially equivalent to femoral components currently marketed under K951987.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
Smith & Nephew, Inc. % Mr. Xiang Zhang, Director of Regulatory Affairs 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K120698
Trade/Device Name: Smith & Nephew Genesis II PS Non-modular and CR Non-modular with cement pocket 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: April 19, 2012 Received: April 20, 2012
Dear Mr. Zhang:
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
3
Page 2 - Mr. Xiang Zhang
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 de rior related adverse oversion (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 11 you donite opertire and 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 note the 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 vou
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K120698
Device Name: Smith & Nephew Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components
INDICATIONS FOR USE:
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for:
- Rheumatoid arthritis. 1.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
Posterior stabilized knee systems are designed for use in patients in primary and revision 4. · surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for use only with cement and are single use devices.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart Cl
(Please Do NoT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K120698