(63 days)
No
The document describes a total knee system and its components, focusing on materials, intended use, and performance testing related to mechanical properties and biocompatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is indicated for use in reconstruction of the diseased knee joint.
No
The device is a total knee replacement system, which is a prosthetic used to reconstruct a diseased knee joint, not to diagnose a condition.
No
The device description clearly states that the device is a "Total Knee System" and describes physical components made of CoCrMo, indicating it is a hardware medical device.
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 reconstructing a diseased knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee replacement system (tibial tray, wedges, etc.), which are physical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
- Performance Studies: The performance studies mentioned are related to the mechanical and material properties of the orthopedic implant, not the accuracy or reliability of a diagnostic test.
In summary, the Columbus (CR) Total Knee System is a surgical implant used for treatment, not a device used to diagnose a condition.
N/A
Intended Use / Indications for Use
The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Columbus Knee (CR) is designed for use with bone cement.
Product codes
JWH
Device Description
The cemented Columbus (CR)Total Knee System additions include a CRA/PSA tibial tray and hemispacers, commonly known as wedges. The CRA/PSA tibial tray and wedges can be used with the existing femoral component, insert, patella and attachment mechanism of the Columbus (CR) Total Knee System cleared via K022672 or with the femoral component and insert of the Columbus (PS) Total Knee System cleared via K030367. The CRA/PSA tibial tray and wedges are manufactured from CoCrMo.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components", and
- "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices" was completed where applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022672, K043440, K032215, K023667, K032479
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.
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510(k) SUMMARY (as required by 21 CFR 807.92) B.
FEB 6 2006
Columbus Total Knee CRA/PSA Tibial tray & w
Columbus (CR) Total Knee System
December 1, 2005
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky
800-258-1946 (phone)
610-791-6882 (fax)
kathy.racosky@aesculap.com (email) |
| TRADE NAME: | Columbus (CR)Total Knee System |
| COMMON NAME: | Total Knee System |
| CLASSIFICATION NAME: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| REGULATION NUMBER: | 888.3560 |
| PRODUCT CODE: | JWH |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Columbus (CR)Total Knee System additions are substantially equivalent to Aesculap's Columbus Total Knee System (K022672), Smith & Nephew's revision knee system (K043440) and PLUS Orthopedic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667), and Howmedica Osteonics's Tibial Tray Screw Hole Plugs (K032479).
DEVICE DESCRIPTION
The cemented Columbus (CR)Total Knee System additions include a CRA/PSA tibial tray and hemispacers, commonly known as wedges. The CRA/PSA tibial tray and wedges can be used with the existing femoral component, insert, patella and attachment mechanism of the Columbus (CR) Total Knee System cleared via K022672 or with the femoral component and insert of the Columbus (PS) Total Knee System cleared via K030367. The CRA/PSA tibial tray and wedges are manufactured from CoCrMo.
INDICATIONS FOR USE
The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Columbus Knee (CR) is designed for use with bone cement.
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TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The CRA/PSA tibial tray and wedges are offered in similar in shapes and sizes as the predicate devices. The material used for the Aseculap device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components", and
- "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices" was completed where applicable.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and location.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 6 2006
Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K053390
Trade/Device Name: Columbus (CR) Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 12, 2006 Received: January 13, 2006
Dear Ms. Racosky:
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 such 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
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Page 2 – Ms. Kathy A. Racosky
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT A.
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Columbus (CR) Total Knee System
Indications for Use:
The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Columbus Knee (CR) is designed for use with bone cement.
| Prescription Use | X | and/or Over-the-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K05 3390 |
|---|---|
| --------------- | ---------- |