(23 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a knee system indicated for reconstruction of diseased knees due to various arthritic conditions, which falls under the definition of a therapeutic device.
No
This device is a knee prosthesis, meaning it is surgically implanted to replace a diseased or damaged knee joint. Its purpose is reconstructive, not diagnostic; it treats an existing condition rather than identifying one.
No
The device description clearly states it is a semi-constrained cemented prosthesis with physical components made of materials like Cobalt Chromium Molybdenum alloy and Ultra High Molecular Weight Polyethylene. It is a physical implant, not software.
Based on the provided information, the VEGA Knee System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for the reconstruction of the knee joint due to various conditions like arthritis and failed arthroplasties. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "semi-constrained cemented prosthesis" made of materials like Cobalt Chromium Molybdenum alloy and Ultra High Molecular Weight Polyethylene. These are materials used for surgical implants, not for testing biological samples in vitro (outside the body).
- 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 about a patient's condition based on such testing.
In Vitro Diagnostic devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The VEGA Knee System is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties 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 VEGA Knee System is designed for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
VEGA Knee System is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. The femoral component, tibial plateau, extension stems and obturators are manufactured from Cobalt Chromium Molybdenum allov (CoCrMo), with an optional Zirconium nitride (ZrN) coating. The tibial gliding surfaces (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The tibial plug is made of PEEK.
VEGA Knee System is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments.
All components are sterile and intended 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)
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 on the VEGA Knee System in support of a substantial equivalence determination. In addition.
- "Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi- Constrained Total Knee Prostheses"
- . "Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA"
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- . "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
- . "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used in Orthopedic Devices"
As a result of the risk analysis, a geometrical comparison was used to determine cross compatibility of VEGA tibial extension stems with Columbus CR/PS and CRA/PSA tibial travs. Results of the geometrical analysis demonstrated no risks of incompatibility related to thread dimensions, diameter and contact area between VEGA tibial extension stems and the intended tibial trays.
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.
K101281, K121879, K140452, K030367
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
Image /page/0/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's logo, which is a stylized caduceus with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle. The logo and text are in black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
Aesculap Implant Systems, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K143106
Trade/Device Name: VEGA Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 24, 2014 Received: October 29, 2014
Dear Ms. Tom 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K143106
Device Name VEGA Knee System
Indications for Use (Describe)
The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, theumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties 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 VEGA Knee System is designed for use with bone cement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Page 1 of 3
B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| VEGA Knee System
| October 24, 2014 | |
|---|---|
| COMPANY: | Aesculap® Implant Systems, LLC |
| 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: | VEGA Knee System |
| COMMON NAME: | Total 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 addition of an uncoated CoCrMo version of the VEGA Knee System, 12mm and 14mm tibial extension stems, each with 12mm length and allowing interchangeability between existing cleared compatible components are substantially equivalent to the currently marketed Aesculap VEGA Knee System (K101281, K121879 and K140452) and Columbus PS Total Knee System (K030367).
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Page 2 of 3
DEVICE DESCRIPTION
VEGA Knee System is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. The femoral component, tibial plateau, extension stems and obturators are manufactured from Cobalt Chromium Molybdenum allov (CoCrMo), with an optional Zirconium nitride (ZrN) coating. The tibial gliding surfaces (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The tibial plug is made of PEEK.
VEGA Knee System is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments.
All components are sterile and intended for single use only.
INDICATIONS FOR USE
The VEGA 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee ioint.
The VEGA Knee System is designed for use with bone cement.
TECHNOLOGICAL CHARACTERISTICS
The option of an uncoated CoCrMo version of the VEGA Knee System. 12mm and 14mm tibial extension stems, each with 12mm length and interchangeability between existing cleared compatible components remain substantially equivalent to the currently marketed Aesculap VEGA Knee System and Columbus Total Knee System (K030367).
VEGA Knee System is currently marketed with a ZrN coating only. The alternate offering of an uncoated CoCrMo version shares the same dimensions, same range of sizes and the same base materials as those offered in the current ZrN coated VEGA Knee system and similarly as that previously cleared in Columbus PS Total Knee System.
The new tibial extension stem share the same design, thread pattern and diameters as currently offered in Columbus and VEGA Knee Systems, only differing in length, 12mm. As those same thread patterns are shared between both Knee Systems, VEGA tibial extension stems may be used with Columbus tibial trays to further complement the existing compatibility previously cleared.
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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 on the VEGA Knee System in support of a substantial equivalence determination. In addition.
- "Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi- Constrained Total Knee Prostheses"
- . "Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA"
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- . "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
- . "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used in Orthopedic Devices"
As a result of the risk analysis, a geometrical comparison was used to determine cross compatibility of VEGA tibial extension stems with Columbus CR/PS and CRA/PSA tibial travs. Results of the geometrical analysis demonstrated no risks of incompatibility related to thread dimensions, diameter and contact area between VEGA tibial extension stems and the intended tibial trays.