(119 days)
Not Found
None
No
The summary describes a knee replacement system and its intended uses, with no mention of AI or ML technology.
Yes
The device is intended for the primary intervention (treatment) of various arthritic conditions and for the replacement of knee components, which are therapeutic actions.
No
Explanation: The provided text describes the indications for use of a knee replacement system, which means it is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
No
The provided text describes the intended use of a knee replacement system, which is a physical implant, not a software-only device. There is no mention of software in the description.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for the knee joint, addressing various conditions like arthritis and bone necrosis. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: While not provided, the intended use strongly suggests a physical implant (femoral components, tibial baseplates, stems).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue), detecting markers, or providing diagnostic information. IVDs are used to diagnose, monitor, or screen for diseases or conditions outside the body.
This device is a surgical implant for knee replacement or reconstruction.
N/A
Intended Use / Indications for Use
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condvie.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
- G. All CONSENSUS® RKS femoral components and tibial baseplates are intended FOR CEMENTED USE ONLY.
- H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.
Product codes
JWH
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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
JUN 2 4 2010
Consensus Orthopedics, Inc. % Mr. Matt Hull Director, QS & RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762
Re: K100542
Trade/Device Name: Consensus® Revision 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: June 14, 2010 Received: June 14, 2010
Dear Mr. Hull:
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
1
Page 2 - Mr. Matt Hull
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 forth in 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 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/ReportalProblem/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.
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K100542
Device Name: Consensus® Revision Knee System
Indications For Use:
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condvie.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
- G. All CONSENSUS® RKS femoral components and tibial baseplates are intended FOR CEMENTED USE ONLY.
- H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Sautu for mxm
(Division Sign Off)
(Dission Sign-Of Division of Surgical, Orthopedic. and Restorative Devices
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510(k) Number K100542