(85 days)
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.
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.
The provided document, K101032 for the Cardo Medical Femoral Cement Restrictor, is a 510(k) premarket notification submission. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive new studies.
Therefore, many of the typical elements of a study proving acceptance criteria (like specific performance metrics, sample sizes, expert adjudication, or MRMC studies) are not present in this document.
Here's a breakdown of the information that can be extracted based on your request, and where details are not available or not applicable for a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing and testing against novel acceptance criteria.
2. Sample size used for the test set and the data provenance
No specific test set or data provenance in terms of patient data is mentioned. The submission states: "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug that does not change the worst-case products for testing purposes, therefore the previous testing applies to these components." This indicates that no new primary clinical or performance testing was conducted for this specific device beyond what was covered by the predicate or the overall knee system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth establishment for performance evaluation is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a cement restrictor, not an imaging or diagnostic device that would typically involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For a physical device like a cement restrictor, "ground truth" typically refers to engineering specifications, material properties, and functional performance (e.g., ability to occlude, biocompatibility). These are implicitly addressed by similarity to the predicate and overall system testing, rather than through complex "ground truth" like in diagnostic AI.
8. The sample size for the training set
Not applicable. This device is a physical medical component, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning algorithm.
Summary of the Study (as described in the 510(k) submission):
The "study" described in this 510(k) is primarily a comparative analysis for substantial equivalence rather than an independent performance study against novel acceptance criteria.
The submission states:
- Synopsis of Test Methods and Results: "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug that does not change the worst-case products for testing purposes, therefore the previous testing applies to these components."
- Comparison to Predicates: The device "is substantially equivalent to the Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479), having the same technological characteristics. The device and its predicate are made of the same material, are used in total knee arthroplasty, and serve the same purpose: to occlude an opening to help prevent bone cement from migrating."
- Conclusion: "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."
Essentially, the "study" for this 510(k) is a declaration and justification that because the new device is technologically equivalent to a legally marketed predicate device (made of the same material, serving the same function, and being non-load-bearing), the safety and effectiveness are also considered equivalent, and no new, specific performance studies beyond what's already established for the predicate or the overall knee system are deemed necessary by the submitter. The FDA's clearance of the 510(k) confirms agreement with this claim of substantial equivalence.
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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.
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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.
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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.
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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
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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
Page 1 of 1
§ 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.