(29 days)
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.
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.
The provided document is a 510(k) summary for the VEGA Knee System, specifically addressing a modification to the wrench size for 10mm extension stems. This document is a premarket notification for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a study with human subjects.
Therefore, many of the requested data points (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable to this type of submission for this particular device modification. The submission focuses on mechanical testing to ensure the modification does not negatively impact the device's performance compared to the predicate.
Here's the information that can be extracted from the provided text, alongside an explanation of why other points are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for mechanical testing) | Reported Device Performance |
|---|---|
| Performance similar to legally marketed VEGA Knee System (K101281) | "The results were found to be similar to the legally marketed VEGA Knee System." |
- Explanation: For this type of modification (wrench size for extension stems), the "acceptance criteria" are implied to be that the modified component, when subjected to mechanical testing, performs comparably to the previously cleared design. The document doesn't specify numerical thresholds for success, but rather a qualitative comparison.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Mechanical testing... was performed," but does not provide the number of samples or specimens tested.
- Data Provenance: The testing was performed internally by the manufacturer (Aesculap Implant Systems, LLC). The nature of the testing is "mechanical testing," implying laboratory-based testing rather than clinical data from a country of origin.
- Retrospective/Prospective: Not applicable. Mechanical testing is a laboratory-based evaluation of physical properties, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was mechanical testing of a physical component (extension stem), not an evaluation of a diagnosis or outcome that would require expert human judgment or "ground truth."
4. Adjudication Method
- Not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study investigates human reader performance (e.g., radiologists, pathologists) often in the context of diagnostic AI. The submission is for a knee implant modification and involves mechanical testing.
6. If a Standalone (Algorithm Only) Performance Study was Done
- Not applicable. This is a medical device (knee implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for mechanical testing is typically established by engineering specifications, material properties, and comparison to the performance of the predicate device under similar testing conditions. It's not "expert consensus," "pathology," or "outcomes data" in the traditional sense for diagnostic or prognostic studies. The implied ground truth is the established performance of the original VEGA Knee System (K101281) through its own mechanical testing.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reasons as #8.
Study that Proves the Device Meets the Acceptance Criteria:
The document states: "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."
This "mechanical testing" is the study referenced. No further details are provided in this summary regarding the specific tests conducted (e.g., fatigue testing, static strength testing), the number of samples, or the quantitative results. The conclusion provided is that the performance was "similar" to the predicate device, indicating it met the implicit acceptance criterion of not degrading performance due to the modification.
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K12187°
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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 PatellofemorotibialPolymer/Metal/Polymer Semi constrainedCemented 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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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.
004
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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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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)
§ 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.