(198 days)
K/DEN number:
No
The document describes a traditional knee implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a knee replacement system used to reconstruct a diseased knee joint, which falls under the definition of a therapeutic intervention to alleviate symptoms and restore function.
No
This device is an orthopedic implant (total knee system) used for surgical reconstruction of the diseased knee joint, not for diagnosing medical conditions.
No
The device description clearly states that the device is a system of physical components (femoral component, tibial plateau, tibial inserts, patellas) made from materials like CoCrMo and UHMWPE, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical reconstruction of the knee joint due to various conditions like osteoarthritis, rheumatoid arthritis, etc. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The device is described as a system of components (femoral, tibial, patella) made from materials like CoCrMo and UHMWPE, designed to replace parts of the knee joint. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic device used in surgery.
N/A
Intended Use / Indications for Use
The Columbus Total Knee System (PS) 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Columbus Knee (PS) is designed for use with bone cement.
Product codes
87 JWH
Device Description
The cemented Columbus Knee System (PS) is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization if the ligament (PCL) is absent, weakened or sacrificed 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)
K021313, K962152, K0994128, K994214, K010101
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
AUG 21 2003
Page 1 of 2
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [in Accordance with SMDA of 1990]
Columbus Total Knee System (PS)
February 4, 2003
-
Aesculap(8), 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 (PS)
COMMON NAME: Columbus Total Knee System (PS)
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 (PS) 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Columbus Knee (PS) is designed for use with bone cement.
DEVICE DESCRIPTION
The cemented Columbus Knee System (PS) is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization if the ligament (PCL) is absent, weakened or sacrificed 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.
1
Columbus Total Knee System
PERFORMANCE DATA
KO 30367 page 1 of 2
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 PS Knee System (K962152) .
- Scorpio Total Stabilizer (K0994128) .
- Gem Knee System (K994214) ●
- Gem PS Total Knee System (K010101) .
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
AUG 21 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Joyce Kilroy Director of Regulatory Affairs and Quality Assurance Aesculap Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K030367
Trade/Device Name: Columbus Total Knee System (PS) Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 4, 2003 Received: June 5, 2003
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), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. 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
K030367 510(k) Number:
Device Name: Columbus Total Knee System (PS)
Indication for Use:
The Columbus Total Knee System (PS) 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Columbus Knee (PS) 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)
(Division Sign-Off) Division of General Restorative and Neuror Ja Ca
510(k) Number K03036
Prescription Use
or Over-the-Counter Use
(per 21 CFR 801.109)