(85 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is for a mechanical component (cement restrictor).
No
The device is described as a 'Femoral Cement Restrictor', an optional accessory for a total knee system, designed to be implanted with bone cement. Its function is to restrict cement, and it is not directly involved in treating disease or restoring function in a therapeutic manner. The Cardo Medical Total Knee System, for which it is an accessory, is a therapeutic device, but the restrictor itself is a component or accessory that facilitates the implantation of the therapeutic device.
No
The device description clearly states "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug..." and the intended use describes it as "for use in individuals undergoing surgery for: Painful, disabling joint disease of the knee..." This indicates it is a surgical accessory used during treatment, not a device used to diagnose a condition.
No
The device description explicitly states it is a "Femoral Cement Restrictor" manufactured from UHMWPE, which is a physical material, not software.
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.
- Device Description: The Cardo Medical Total Knee System and the Femoral Cement Restrictor are described as implants and accessories used in surgical procedures (total knee arthroplasty). They are physically implanted into the body.
- Intended Use: The intended use clearly states that the system is for individuals undergoing surgery for painful and disabling joint disease of the knee. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided describes a surgical implant and its accessory, which are medical devices used in vivo (within the body), not in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Cardo Medical Cement Restrictor is for use at the option of the surgeon in total knee arthroplasty to occlude the opening in the femoral component to help prevent bone cement migration. Because the device may only be used in total knee arthroplasty, it carries the indications for use for the overall system: The Cardo Medical Total Knee System is indicated for use in individuals undergoing surgery for: · Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; · Post-traumatic loss of knee joint configuration and function · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; · Revisions of previous unsuccessful knee replacement or other procedures. Additional indications for posteriorly stabilized components: · Ligamentous instability requiring implant bearing surfaces with increased constraint; · Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH, LZN
Device Description
The Cardo Medical Femoral Cement Restrictor is only intended for use with Cardo Medical PS femoral components (previously cleared in K081127). The device is an optional accessory and is manufactured from UHMWPE.
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)
Synopsis or rese mothed and non-load-bearing plug that does not change the worst case products for testing purposes, therefore the previous testing applies to these components.
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.
Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479)
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.
Cardo Medical Inc. Total Knee System (K081127)
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
Cardo Medical Femoral Cement Restrictor Premarket Notification Submission - 510(k)
Image /page/0/Picture/2 description: The image shows the logo for Cardo Medical. The logo consists of a stylized graphic to the left of the words "Cardo Medical" stacked on top of each other. Below the logo is the address "10 Clifton Blvd. Suite B1 Clifton, NJ 07011".
JUL--8 2010
Summary of Safety and Effectiveness
Cardo Medical, Inc. Submitter/Owner: 10 Clifton Blvd., Suite B1, Clifton, NJ 07011
Dina L. Weissman, J.D. Contact Person: Director, Quality Assurance, Regulatory Affairs and Government Compliance 973-777-8832 Phone: Fax: 973-777-8851 dweissman@cardomedical.com
July 2, 2010 Date Prepared:
Cardo Medical Femoral Cement Obturator Trade Name:
Email:
Cement Obturator Common Name:
Surgical Mesh, (21 CFR 878.3300, Product Code: LZN, Class II) and Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, (21 CFR 888.3560, Product Code: JWH, Class II)
Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479) Predicate Device: Cardo Medical Inc. Total Knee System (K081127, cleared as ACCIN Total Knee System)
The Cardo Medical Femoral Cement Restrictor is only intended for use with Device Description: Cardo Medical PS femoral components (previously cleared in K081127). The device is an optional accessory and is manufactured from UHMWPE.
The Cardo Medical Cement Restrictor is for use at the option of the surgeon in Intended Use: total knee arthroplasty to occlude the opening in the femoral component to help prevent bone cement migration. Because the device may only be used in total knee arthroplasty, it carries the indications for use for the overall system:
The Cardo Medical Total Knee System is indicated for use in individuals undergoing surgery for:
· Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
· Post-traumatic loss of knee joint configuration and function
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
· Revisions of previous unsuccessful knee replacement or other procedures.
Additional indications for posteriorly stabilized components:
· Ligamentous instability requiring implant bearing surfaces with increased constraint;
· Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
1
Cardo Medical Femoral Cement Restrictor Premarket Notification Submission - 510(k)
Comparison to Predicates:
The Cardo Medical Femoral Cement Restrictor is an ultrahigh molecular weight polyethylene component for use in total knee arthroplasty. The device is substantially equivalent to the Howmedica Osteonics 7 for use in total kneed annoplaty. 176 02479), having the same technological characteristics. The Tibler Tray Done Oceew The same material, are used in total knee arthroplasty and serve device and its predioute are opening to help prevent bone cement from migrating.
Cardo Medical, Inc. has determined that any differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use.
Synopsis of Test Methods and Results:
Oynopsis or rese mothed and non-load-bearing plug that does not change the worst case products for testing purposes, therefore the previous testing applies to these components.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines. The overall design is simple and conveys a sense of national identity and governmental authority.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardo Medical, Inc. % Ms. Dina L. Weissman. J.D. Director, Quality Assurance Regulatory Affairs and Government Compliance 10 Clifton Boulevard, Suite B1 Clifton, New Jersey 07011
Re: K101032
Trade/Device Name: Cardo Medical Total Knee System - Femoral Cement Restrictor Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis
JUL - 8 2010
Regulatory Class: II Product Codes: JWH: LZN Dated: April 13, 2010 Received: April 14, 2010
Dear Ms. Weissman:
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. Iisting 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.
3
Page 2 - Ms. Dina L. Weissman, J.D.
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 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/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.
Kaibau Buchur
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 Statement
0103
510(k) Number (if known):
Device Name: Cardo Medical Total Knee System - Femoral Cement Restrictor
INDICATIONS FOR USE
The Cardo Medical Total Knee System is indicated for use in individuals undergoing surgery for:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function ●
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
- . Revisions of previous unsuccessful knee replacement or other procedures.
Additional indications for posteriorly stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint; �
- Absent or non-functioning posterior cruciate ligament. .
These devices are single use only and are intended for implantation with bone cement.
Prescription Use XXX (Per 21 CFR 801 Subpart D) 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)
barbare buehm.
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101632
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