(30 days)
The Columbus 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.
The Columbus Total Knee System AS includes both CR and PS variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts. The Zirconium Nitrate ZrN coating is the only change to the previously cleared Columbus Total Knee System. The coated components are still made from Cobalt Chrome alloy (CoCrMo).
The provided document is a 510(k) summary and FDA clearance letter for the Columbus Total Knee System AS. It describes a medical device, a knee implant, and its substantial equivalence to previously cleared devices.
However, this document does not contain any information about a study involving acceptance criteria for device performance based on AI/algorithm performance. The "PERFORMANCE DATA" section states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications All roquired (50.mg per or Orthopedic Devices-The Basic Elements' were done where applicable." This refers to standard engineering and biocompatibility testing for orthopedic implants, not an AI-based performance study.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or AI-related effectiveness studies, as this information is not present in the provided text.
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Columbus Total Knee System AS
4071220 (1/2)
| Page 1 of 2B. | 510(k) SUMMARY (as required by 21 CFR 807.92) | JUN - 1 2007 |
|---|---|---|
| Columbus Total Knee System AS2 May 2007 | ||
| COMPANY: | Aesculap® Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 | |
| CONTACT: | Matthew M. Hull800-258-1946 (phone)610-791-6882 (fax)matt.hull@aesculap.com (email) | |
| TRADE NAME: | Columbus Total Knee System AS | |
| 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 Total Knee System Alternate Surface (AS) is substantially equivalent to Aesculap's Columbus Total Knee System PS (K030367), CR (K022672), Smith & Nephew's Genesis II Zirconium "Oxinium" knee (K962557), and Endotec's (B-P) New Jersey Total knee (K012702).
DEVICE DESCRIPTION
The Columbus Total Knee System AS includes both CR and PS variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts. The Zirconium Nitrate ZrN coating is the only change to the previously cleared Columbus Total Knee System. The coated components are still made from Cobalt Chrome alloy (CoCrMo).
INDICATIONS FOR USE
The Columbus 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.
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Page 2 of 2
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The base material used for the new Aseculap implants is the same as that used to r re base material adsculap devices. The only difference is the addition of a The nium Nitrate (ZrN) coating to the CoCrMo implants. The PVD coating method is Elroomian Nitrate (EPT) council devices as well including the other predicate implants.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications All roquired (50.mg per or Orthopedic Devices-The Basic Elements" were done where applicable.
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Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap Implant Systems, Inc. % Mr. Matthew M. Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
JUN - 1 2007
Re: K071220
Trade/Device Name: Columbus Total Knee Systems AS Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: II
Product Code: JWH Dated: May 2, 2007 Received: May 10, 2007
Dear Mr. Hull:
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
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Page 2 – Mr. Matthew Hull
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 toll-free number (800) 638-2041 or (240) 276-3150 or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millman
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
INDICATIONS FOR USE STATEMENT A.
510(k) Number: 14071220
Device Name: Columbus Total Knee System AS
Indications for Use:
The Columbus Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, theumatoid 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.
Mark N. Millheim
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Prescription Use__
Prescription Use
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.