(30 days)
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for use in the reconstruction of diseased knee joints due to various arthritis types, indicating it is used to treat or manage a disease.
No
The device description indicates it is a knee prosthesis system used for reconstruction of the diseased knee joint, not for diagnosing conditions.
No
The device description explicitly details physical components made of materials like CoCrMo, UHMWPE, and PEEK, indicating it is a hardware-based medical device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's purpose as a surgical implant for reconstructing the knee joint due to various conditions. This is a therapeutic and reconstructive function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details the materials and components of a knee prosthesis, which is an implantable medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
Therefore, the Columbus REVISION Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Columbus REVISION 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 corrective valgus or varus deformity and moderate flexion contracture.
The Columbus REVISION Knee System is designed for use with bone cement.
Product codes
JWH
Device Description
The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).
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)
Customized endurance testing based on ASTM F 2722-08 was performed on Aesculap Implant Systems Columbus REVISION tibial gliding surfaces, tibial post and fixation screw for 10 million cycles as a result of the risk assessment. The results were found to be similar to the legally marketed Columbus REVISION Knee System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K122985
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS B.
Columbus REVISION Knee System October 24, 2012
Aesculap® Implant Systems, LLC COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
ESTABLISHMENT
REGISTRATION NUMBER: 3005673311
CONTACT:
Julie Tom Wing 610-984-9147 (phone) 610-791-6882 (fax) Julie. TomWing@aesculap.com
DEVICE
| TRADE NAME: | REVISION |
|---|---|
| COMMON NAME: | Columbus REVISION Knee System |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | JWH |
| REGULATION NUMBER: | 888.3560 |
| CLASSIFICATION NAME: | Knee Joint Patellofemorotibial |
| Polymer/Metal/Polymer Semi-constrained | |
| Cemented Prosthesis |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the modification to Columbus REVISION Knee System remains substantially equivalent to Aesculap Implant Systems Columbus REVISION Knee System originally cleared in 510(K) K083772.
DEVICE DESCRIPTION
The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).
OCT 26 2012
1
K122985 Page 2 of 2
INDICATIONS FOR USE
The Columbus REVISION 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 corrective valgus or varus deformity and moderate flexion contracture.
The Columbus REVISION Knee System is designed for use with bone cement.
TECHNOLOGICAL CHARACTERISTICS (Compared to the Predicate)
The entire Columbus REVISION Knee System was cleared under K083772. The fundamental scientific technology and materials for the Columbus REVISION Knee System remain the same. The only difference is a design modification of the posterior stabilizing (PS) tibial post of the medium constraint (MC) and high constraint (HC) gliding surfaces (inserts).
PERFORMANCE DATA
Customized endurance testing based on ASTM F 2722-08 was performed on Aesculap Implant Systems Columbus REVISION tibial gliding surfaces, tibial post and fixation screw for 10 million cycles as a result of the risk assessment. The results were found to be similar to the legally marketed Columbus REVISION Knee System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculan Implant System, Incorporated % Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K122985
Trade/Device Name: Columbus REVISION Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 20, 2012 Received: September 26, 2012
Dear Ms. Wing:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Julie Tom Wing
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
1122985 510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Columbus REVISION Knee System
Indications for Use:
The Columbus REVISION 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 REVISION Knee System is designed to for use with bone cement.
| Prescription Use | X |
|---|---|
| and/or Over-the-Counter 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122988
002