(29 days)
Not Found
No
The document describes a mechanical knee implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a knee replacement system used to reconstruct a diseased knee joint, indicating its therapeutic purpose in alleviating pain, restoring function, and correcting deformities.
No
The device, the VEGA Knee System, is a prosthesis intended for reconstruction of the diseased knee joint. Its purpose is to replace malfunctioning body parts, not to diagnose medical conditions or identify diseases.
No
The device description clearly states it is a "semi-constrained cemented prosthesis" made of various materials like CoCrMo, ZrN, UHMWPE, and PEEK, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the surgical reconstruction of a diseased knee joint. This is a surgical implant, not a test performed on a sample taken from the body.
- Device Description: The device description details the materials and components of a knee prosthesis (femoral component, tibial plateau, inserts, patella, etc.). These are physical implants.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The VEGA Knee System is a surgical implant used to replace a damaged knee joint.
N/A
Intended Use / 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 joint.
The VEGA Knee System is designed for use with bone cement.
Product codes
JWH
Device Description
The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Mechanical testing of the Aesculap Implant Systems VEGA 10mm extension stems was performed as a result of the risk assessment. The results were found to be similar to the legally marketed VEGA Knee System.
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.
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K12187°
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS B.
JUL 2 7 2012
VEGA Knee System June 20, 2012
COMPANY:
CONTACT:
Aesculap® Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034
ESTABLISHMENT
REGISTRATION NUMBER: 3005673311
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 modification to VEGA Knee System remain substantially equivalent to Aesculap Implant Systems VEGA Knee System originally cleared in 510(K) K101281.
DEVICE DESCRIPTION
The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug 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.
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Page 2 of 2
INDICATIONS FOR USE
The VEGA 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.
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 (Compared to the Predicate)
The entire VEGA Knee System was cleared under K101281. The fundamental scientific technology and materials for the VEGA system remain the same. The only difference is the design modification of wrench size to VEGA 10mm extension stems.
PERFORMANCE DATA
Mechanical testing of the Aesculap Implant Systems VEGA 10mm extension stems was performed as a result of the risk assessment. The results were found to be similar to the legally marketed VEGA Knee System.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is composed of three abstract, curved lines, representing the health and well-being aspect of the department's mission. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2012
Aesculap Implant Systems, LLC % Ms. Julie Tom Wing 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K121879
Trade/Device Name: VEGA 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: June 26, 2012
Received: June 28, 2012
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 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.
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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,
Erine Keith
J / Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number:
Device Name: VEGA Knee System
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.
V-121279
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.
A
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121879
Prescription Use × 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)