(105 days)
Not Found
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 or ML.
Yes
The VKS Knee System is a medical device intended for surface replacement in total knee arthroplasty, which is a therapeutic procedure to treat a medical condition (damaged knee joint).
No
Explanation: The VKS Knee System is a prosthetic device (total knee prosthesis) used for surgical replacement, not for diagnosing medical conditions. Its intended use describes treatment, not diagnosis.
No
The device description explicitly states it is comprised of physical components (femoral, patellar, and tibial components with a PE-insert), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The VKS Knee System is a prosthetic implant designed to replace parts of the knee joint. It is surgically implanted into the body.
- Intended Use: The intended use is for surgical replacement of the knee joint in patients with certain conditions. This is a therapeutic intervention, not a diagnostic test performed on specimens outside the body.
The information provided clearly describes a surgically implanted medical device, not a diagnostic test.
N/A
Intended Use / Indications for Use
The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The VKS Knee System is a tri-compartmental total knee prosthesis comprised of femoral, patellar and tibial components with an intrinsic tibial PE-insert. Standard, and Ultra-Congruent tibial components are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Biomechanical Testing has been provided. All test results are sufficient for in vivo loading.
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.
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
OCT 1 8 2002
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
PLUS ORTHOPEDICS Contact: 6055 Lusk Blvd. San Diego, CA 92121
- VKS Knee System Trade name:
Common name: Knee Joint Prosthesis
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Classification name: Polymer/Metal/Polymer. & 21 CFR 888.3560, Class II, 87 JWH
TC-PLUS™ Solution Knee System (K000666, SE date 10/13/2000) Equivalence:
The VKS Knee System is a tri-compartmental total knee prosthesis Characteristics: comprised of femoral, patellar and tibial components with an intrinsic tibial PE-insert. Standard, and Ultra-Congruent tibial components are available.
- The VKS Knee System is intended as a cemented surface replacement Indications: in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
- Contraindications include acute or chronic infections (local or systemic) Contraindications: or a history of infection; severe muscular, neurological, or vascular deficiencies which compromise the affected extremity: bone defects or insufficient bone quality which may affect the stability of the implant; any concomitant illness which may compromise the function of the implant; severe obesity; allergy to the implant materials; subluxation of the femur against the eminentia; ligament instability; severe varus or valgus misalignment; retropatellar degenerative arthritis; extension contractures over 10°.
- Performance data: Biomechanical Testing has been provided. All test results are sufficient for in vivo loading.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca Wahl Consultant, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121
Received: October 4, 2002
Re: K022204
Trade/Device Name: VKS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: October 3, 2002
Dear Ms. Wahl:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice
2
Page 2 - Ms. Rebecca Wahl
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
l Mark N. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page .
510(k) Number: K022204
Device Name(s):
VKS KNEE SYSTEM
Indications for Use:
The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022204 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter-Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional format 1-2-96) |