(88 days)
Not Found
No
The document describes a traditional knee replacement system and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
This device is a total knee replacement system used for reconstructing a diseased knee joint, which is a therapeutic intervention.
No
The device, the Columbus Total Knee System, is described as an implant for knee reconstruction, not as a tool used to diagnose conditions. Its intended use is for treating diseased knee joints, not for identifying the disease.
No
The device description explicitly states that the device is a system of physical components (femoral component, tibial plateau, tibial inserts, and patellas) made from materials like CoCrMo and UHMWPE, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and genetic tests.
- The Columbus Total Knee System is a surgical implant. It is a prosthetic device designed to replace a diseased knee joint. It is implanted directly into the patient's body during surgery.
The provided information clearly describes a medical device used for surgical reconstruction of a joint, not a device used to test samples from the body.
N/A
Intended Use / Indications for Use
The Columbus Total Knee System (CR) is indicated for use in reconstruction of the diseased knee ioint 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
87 JWH
Device Description
The cemented Columbus Knee System (CR) is available with one femoral design, the Cruciate Retaining (CR) which retains the ligament (PCL) during implantation. The design of the femoral component, and tibial plateau (tray) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
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) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market.
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
Columbus Total Knee System
8 2002 NOV
02267d
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS c. [in Accordance with SMDA of 1990]
Columbus Total Knee System (CR)
April 1, 2001
Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 2916714
- Joyce Kilroy CONTACT: 800/258-1946 x 5074 (phone) 610/791-6882 (fax)
- TRADE NAME: Columbus (CR)
- COMMON NAME: Columbus Total Knee System (CR)
DEVICE CLASS: Class II
PRODUCT CODE: 87 JWH
- CLASSIFICATION: 888.3560 Prosthesis, Knee, Patellofemortibial Semi-constrained, Cemented, polymer/metal/polymer
- REVIEW PANEL: Orthopedics
INDICATIONS FOR USE
The Columbus Total Knee System (CR) is indicated for use in reconstruction of the diseased knee ioint 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.
1
K020672
page 2 of 2
DEVICE DESCRIPTION
The cemented Columbus Knee System (CR) is available with one femoral design, the Cruciate Retaining (CR) which retains the ligament (PCL) during implantation. The design of the femoral component, and tibial plateau (tray) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Columbus Total Knee System is substantially equivalent to:
- . Search Evolution Total Knee System (K021313)
- Scorpio Posterior Cruciate Retaining Knee System (K974556) .
- . Gem Knee System (K994214)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles three abstract human profiles or faces, with flowing lines suggesting movement or connection.
Public Health Service
NOV 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Joyce Kilroy Director of Regulatory Affairs/Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K022672
Trade/Device Name: Columbus Total Knee System (CR) 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 9, 2002
Received: August 12, 2002
Dear Ms. Kilroy:
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. Joyce Kilroy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
L. Mark N. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT B.
Page 1 of 1
Device Name: Columbus Total Knee System (CR)
Indication for Use:
The Columbus Total Knee System (CR) 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 to for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
or Over-the-Counter Use
Mark N. Mulkerson
ision of General, Rest rative and Neurologica
510(k) Number K022672