(106 days)
No
The summary does not mention AI, ML, or any related technologies. The device description and performance studies focus on traditional orthopedic device testing and materials.
Yes
The device is intended for the reconstruction of the diseased knee joint, which is a therapeutic purpose.
No
The device is a knee replacement system used for reconstruction of the diseased knee joint, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, single-use tibial tray, which is a physical implant component, not software.
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 a sterile, single-use tibial tray intended for use within a total knee system. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, treatment, or prevention of disease.
Therefore, the Columbus (CR) Total Knee System and its components, like the Columbus MIOS CR/PS tibial tray, are classified as orthopedic implants, not IVDs.
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 is designed for use with bone cement.
Product codes
JWH
Device Description
The Columbus MIOS CR/PS tibial tray is a sterile, single-use device that is intended to be used with the previously cleared femoral component, insert, patella, and attachned to mechanism of the Columbus (CR) Total Knee System or with the femoral component and insert of the Columbus (PS) Total Knee System.
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)
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
SEP 1 4 2007
Page 1 of 2
Columbus Total Knee System MIOS CR/PS Tibial Tray
510(k) SUMMARY (as required by 21 CFR 807.92) в.
| Columbus (CR) Total Knee System
(MIOS CR/PS Tibial Tray)
| May 31, 2007 | |
|---|---|
| COMPANY: | Aesculap Implant Systems Inc. |
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: 3005673311 | |
| CONTACT: | Kathy A. Racosky |
| 610-984-9291 (phone) | |
| 610-791-6882 (fax) | |
| kathy.racosky@aesculap.com (email) | |
| TRADE NAME: | Columbus Total Knee System MIOS CR/PS Tibial |
| Tray | |
| 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 Implant Systems Inc. believes that the Columbus Total Knee System MIOS CR/PS Tibial Tray is substantially equivalent to Aesculap Implant Systems Inc. Columbus Total Knee System (K022672), Howmedica Osteonics Scorpio J ow Profile Tibial Tray (K032829), and Zimmer's Millar/Galante Precoated Total Knee (K853661).
DEVICE DESCRIPTION
The Columbus MIOS CR/PS tibial tray is a sterile, single-use device that is intended to be used with the previously cleared femoral component, insert, patella, and attachned to mechanism of the Columbus (CR) Total Knee System or with the femoral component and insert of the Columbus (PS) 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, theumatoid arthritis, post-traumation of this, 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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Page 2 of 2
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The MIOS CR/PS tibial tray is offered in similar shapes and sizes as the predicate devices. The base material used for the Aseculap Implant Systems device is the same as that used to manufacture the predicate devices. The only difference is a PMMA Nano-Bond surface pretreatment to the CoCrMo implants. The materials used in the PMMA Nano-Bond surface pretreatment are commonly used on other medical 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 is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
SEP 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773Corporate Parkway Center Valley, PA 18034
Re: K071499
Trade/Device Name: Columbus Total Knee System MIOS CR/PS Tibial Tray 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: August 20, 2007 Received: August 21, 2007
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 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.
3
Page 2 -- Ms. Kathy A. Racosky
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Barbara Buchus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
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 is designed for use with bone cement.
X Prescription Use
(per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -- Goneurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
510(k) Nun