(262 days)
Not Found
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device, a total knee replacement system, is used to reconstruct diseased knee joints and revise failed arthroplasties, addressing medical conditions and restoring bodily function.
No
Explanation: The device is a total knee system, an orthopedic implant used for joint reconstruction, not for diagnostic purposes. Its intended use describes treatment of diseased knee joints.
No
The device description clearly details physical components made of materials like CoCrMo, UHMWPE, and PEEK Optima®, indicating it is a hardware medical device (a knee implant system).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a surgical implant for reconstructing the knee joint due to various conditions like osteoarthritis, rheumatoid arthritis, etc. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The description details the materials and components of a knee prosthesis (femoral component, tibial plateau, inserts, etc.). These are physical implants, not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status based on in vitro testing.
The device is a surgical implant used to treat a physical condition of the knee joint.
N/A
Intended Use / Indications for Use
Columbus Total Knee System AS:
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.
EnduRo Knee System:
The EnduRo 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. Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. The EnduRo Knee System is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, KRO
Device Description
Columbus Total Knee System AS:
The Columbus Total Knee System AS includes both "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts and patellae. The tibial hemi-spacers (wedges) are the same design as the previously cleared Columbus Total Knee System (CRA/PSA) (K053390). All components manufactured from CoCrMo are coated with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220).
EnduRo Knee System:
The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" (insert) and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (Zirconium nitride) coating. All components are sterile and for single use only.
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)
Columbus Total Knee System AS:
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. Design verification of the Columbus Total Knee System AS was performed as a result of the risk assessment which were determined to be substantially equivalent to the predicates.
EnduRo Knee System:
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. Mechanical testing to evaluate the resistance against loosening of the screw connection of the tibia component and the tibia locking ring of Aesculap EnduRo Knee System was performed for 5 million cycles. Results were found to be substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Columbus Total Knee System AS:
K071220, K053390
EnduRo Knee System:
K101815
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Premarket Notification
Columbus Total Knee System AS
Page 1 of 2
DEC 1 7 2002 |
510(k) SUMMARY (as required by 21 CFR 807.92)
Columbus Total Knee System AS December 17, 2012
COMPANY:
Aesculap® Implant Systems, Inc. 3773 Corporate Parkway Center Valley. PA 18034 Establishment Registration Number: 3005673311
CONTACT:
Julie Tom Wing 800-234-9179 (phone) 610-791-6882 (fax) julie tomwing@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
The Columbus Total Knee System Alternate Surface (AS) is substantially equivalent to Aesculap's Columbus Total Knee System (K071220) and the previously cleared Columbus Total Knee System (CRA/PSA) (K053390).
DEVICE DESCRIPTION
The Columbus Total Knee System AS includes both "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts and patellae. The tibial hemi-spacers (wedges) are the same design as the previously cleared Columbus Total Knee System (CRA/PSA) (K053390). All components manufactured from CoCrMo are coated with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220).
1
Page 2 of 2
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 valous or varus deformity and moderate flexion contracture.
The Columbus Knee is designed for use with bone cement.
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))
The base materials used for the new Aseculap implants are the same as that used to manufacture the predicate Aesculap devices. The only differences are a line extension introducing narrow CR and PS femurs and an introduction of AS coated tibial hemispacers including a smaller size (0/0+) hemi-spacer.
The Columbus narrow femurs are a dimensional modification that is available in right and left configurations in sizes that fall within the size range of femoral components previously cleared in Columbus AS Total Knee System (AS) (K071220).
The AS coated tibial hemi-spacers are a design change to the previously approved hemispacers cleared in K053390. The smaller size (0/0+) hemispacer is designed to mate with the same standard size or respective plus-size trays (i.e. TO wedge/T0+ tibial tray). The AS coating was cleared previously in K071220.
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.
Design verification of the Columbus Total Knee System AS was performed as a result of the risk assessment which were determined to be substantially equivalent to the predicates.
2
510(k) Premarket Notification
EnduRo Knee System
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92)
EnduRo Knee System December 17, 2012
COMPANY:
Aesculap® Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
CONTACT:
Julie Tom Wing 800-234-9179 (phone) 610-791-6882 (fax) julie tomwing@aesculap.com (email)
TRADE NAME: EnduRo Knee System
COMMON NAME: Total Knee System
CLASSIFICATION NAME: Prosthesis. Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
REGULATION NUMBER: 888.3510
PRODUCT CODE: KRO
SUBSTANTIAL EQUIVALENCE
The EnduRo Knee System is substantially equivalent to previously cleared, Aesculap Implant Systems EnduRo Knee System (K101815).
DEVICE DESCRIPTION
The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" (insert) and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (Zirconium nitride) coating. All components are sterile and for single use only.
3
Page 2 of 2
INDICATIONS FOR USE
The EnduRo Knee System 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.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))
The base materials used for the new Aseculap implants are the same as that used to manufacture the predicate Aesculap devices. The only difference is a design modification to the locking nut.
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.
Mechanical testing to evaluate the resistance against loosening of the screw connection of the tibia component and the tibia locking ring of Aesculap EnduRo Knee System was performed for 5 million cycles. Results were found to be substantially equivalent to the predicate.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 17, 2012
Aesculap Implant System, LLC % Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K120955
Trade/Device Name: COLUMBUS Total Knee System AS and EnduRo Knee System Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Codes: JWH, KRO Dated: December 13, 2012 Received: December 14, 2012
Dear Ms. Tom Wing:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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
5
Page 2 -- Ms. Julie Tom Wing
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Columbus Total Knee System AS
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number:_
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, 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.
× and/or Over-the-Counter Use Prescription Use (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINEACONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
K120955
510(k) Number .
7
Page 1 of 1
A.
510(k) Number:_
Device Name: EnduRo Knee System
The EnduRo 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.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
| 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)
and Restorative Devices
| 510(k) Number | K120955 |
|---|---|
| --------------- | --------- |