(103 days)
Not Found
No
The summary describes a physical medical device (patella component for knee replacement) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a patella component used in knee arthroplasty to treat degenerative arthritis, patellar dislocation or fracture, and failed previous surgeries, which clearly indicates its use in treating and alleviating medical conditions.
No
Explanation: The device is a patella component, an implant used in knee arthroplasty, and its intended use is to replace or resurface the patella. It does not gather information from the patient to determine the presence or absence of a disease or condition.
No
The device description clearly states the device is a physical component (patella) manufactured from UHMWPE with pegs, intended for surgical implantation. This is a hardware device, 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 provided text describes a physical implant (a patella component) used in surgical procedures (knee arthroplasty). It is a medical device intended for implantation within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states the device is for "patellofemoral knee arthroplasty" and "total knee arthroplasty," which are surgical procedures.
Therefore, based on the provided information, the Cardo Medical Patellofemoral System patella components are not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardo Medical Align 360® Medialized Patella Component is intended for cemented use in resurfacing the patella during patellofemoral disease or during total knee replacement. Patient's with patellofemoral disease may have Degenerative arthritis in the distal femur and patella; a history of patellar dislocation or fracture; or failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain deformity or dysfunction persists; whereas patients obtaining a total knee arthroplasty may have 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; or revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilized components include ligamentous instability requiring implant bearing surfaces with increased constraint; or absent or non-functioning posterior cruciate ligament.
When used with the Patello-femoral System:
The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with:
- Degenerative arthritis in the distal femur and patella; .
- A history of patellar dislocation or fracture; .
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists.
When used with the Total Knee System:
The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis;
- Post-traumatic loss of knee joint confiquration 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 procedure. .
Additional indications for posteriorly stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint: .
- Absent or non-functioning posterior cruciate ligament. .
The patella components are single use only and intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH, KRR
Device Description
The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPE with pegs on the non-articulating surface. The surgeon uses the components to resurface the patella during either a patella-femoral replacement or a total knee replacement. The device is designed for cemented fixation only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Patella, Distal Femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, 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
Tests were performed on the Align 360° Medialized patellae system to ensure the proposed device is equivalent to the predicate device for all testing performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed on the Align 360° Medialized patellae system to ensure the proposed device is equivalent to the predicate device for all testing performed.
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.
K073120, K081127, K962152, K972967
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
Cardo Medical Align 360 Medialized Patella Component Premarket Notification Submission - 510(k)
| Submitter: | Dave Lamb
Cardo Medical Corporation
10 Clifton Blvd., Suite B1
Clifton, NJ 07011 | Summary of Safety and Effectiveness
DEC 2 3 2009 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Date Prepared: | November 18, 2009 | |
| Device: | Cardo Medical Align 360® Medialized Patella Component | |
| Classification: | 87KRR - Knee joint patellofemoral polymer/metal semi-constrained cemented,
21CFR 880.3540, Class II; and 87JWH Prosthesis, knee, patellofemorotibial,
semi-constrained cemented polymer/metal/polymer, 21 CFR 888.3560, Class II. | |
| Predicate Device: | Cardo Medical Dome Patella - K073120 (used with patellofemoral joint), Cardo
Medical Dome Patella - K081127 (used with Total Knee System), and Scorpio
Knee System - K962152 and K972967. | |
| Device Description: | The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPE
with pegs on the non-articulating surface. The surgeon uses the components to
resurface the patella during either a patella-femoral replacement or a total knee
replacement. The device is designed for cemented fixation only. | |
| Intended Use: | The Cardo Medical Align 360® Medialized Patella Component is intended for cemented
use in resurfacing the patella during patellofemoral disease or during total knee
replacement. Patient's with patellofemoral disease may have Degenerative arthritis in the
distal femur and patella; a history of patellar dislocation or fracture; or failed previous
surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain deformity or
dysfunction persists; whereas patients obtaining a total knee arthroplasty may have
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; or revisions of
previous unsuccessful knee replacement or other procedure. Additional indications for
posteriorly stabilized components include ligamentous instability requiring implant bearing
surfaces with increased constraint; or absent or non-functioning posterior cruciate
ligament | |
Comparison to Predicates:
The Cardo Medical Align 360° Medialized Patella components are manufactured from UHMWPE have the same articulating surface as the current dome patella. The only difference is the additional material around the edge of the dome. Therefore, the devices are equivalent to the current Cardo Medical Dome Patella. In addition the Stryker, Scorpio Knee System has an oval patella component, which is a similar shape to the Cardo Medialized Patella proposed in this submission.
Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the Align 360° Medialized patella components for their intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.
Synopsis of Test Methods and Results:
Tests were performed on the Align 360° Medialized patellae system to ensure the proposed device is equivalent to the predicate device for all testing performed.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 2 3 2009
Cardo Medical Corporation % Mr. David Lamb 10 Clifton Boulevard, Suite B1 Clifton, New Jersey 07011
Re: K092803
Trade/Device Name: Cardo Medical Align 360® Medialized Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, KRR Dated: December 7, 2009
Received: December 14, 2009
Dear Mr. Lamb:
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.
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 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.
2
Page 2 - Mr. David Lamb
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.fdai.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Form
1
| 510(k) Number (if known): | K042803 |
|---|---|
| --------------------------- | --------- |
Device Name: Cardo Medical Align 3600 Medialized Patella
Indications for Use:
When used with the Patello-femoral System:
The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with:
- Degenerative arthritis in the distal femur and patella; .
- A history of patellar dislocation or fracture; .
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists.
When used with the Total Knee System:
The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis;
- Post-traumatic loss of knee joint confiquration 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 procedure. .
Additional indications for posteriorly stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint: .
- Absent or non-functioning posterior cruciate ligament. .
The patella components are single use only and intended for implantation with bone cement.
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
FOR M. MELKERSON
(Division Sign-Off) Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092803