(18 days)
No
The document describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a revision knee arthroplasty system, which is a medical implant used to treat patients requiring knee replacement, thereby falling under the definition of a therapeutic device.
No
This device is a revision knee arthroplasty system, a type of implant used in surgery, not a tool for diagnosis. Its intended use is for patients undergoing knee arthroplasty, and its description details its components as a prosthetic device.
No
The device description clearly outlines physical components such as a femoral component, tibial baseplate, tibial insert, augmentation blocks, and intramedullary stems, indicating it is a hardware medical device.
Based on the provided information, the VKS/TC-PLUS Revision Knee is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "revision knee arthroplasty," which is a surgical procedure to replace a previously implanted knee prosthesis. This is a therapeutic intervention performed on a patient's body.
- Device Description: The device is described as a "tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems." These are physical implants designed to be surgically placed within the knee joint.
- Anatomical Site: The anatomical site is the "Knee," indicating it's used within the human body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VKS/TC-PLUS Revision Knee does not perform this function; it is a medical device used for surgical implantation.
N/A
Intended Use / Indications for Use
The VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision knee arthroplasty where the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, or connective tissue disorders. It is for cemented use only.
Product codes
JWH
Device Description
The VKS/TC-PLUS Revision Knee is a tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems.
The VKS/TC-PLUS Revision femoral component is available in five size and right and left configurations. It has a post in the box into which is machined a female Morse type taper to receive an intramedullary stem. It is also configured to received posterior and distal augmentation blocks.
The VKS/TC-PLUS Revision tibial baseplate has five sizes, right and left, and has the same outer profile as the VKS baseplates cleared in K022204. The tibial insert locking mechanism is the VKS Knee. The inferior surface of the baseplate has a short post with a female type taper machined into it to receive modular stems and a hole through the baseplate to receive a screw to augment the baseplate/stem connection. The stems are as used on the femoral component. The inferior surface of the baseplate also has two fins that extend posterior/laterally from the post.
The same ultra-congruent insert cleared with the VKS Knee under K022204 is used with the VKS/TC-PLUS Revision Knee.
The femoral augmentation blocks are available in distal and posterior configurations, 5mm and 10mm thickness. The tibial augmentation blocks are available in half blocks so that medial, lateral or full augmentation can be achieved. They are also available in 5mm and 10mm thickness.
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)
Engineering analysis indicates that the VKS/TC-PLUS Revision Knee is as strong as its predicate devices.
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.
0
Date July 17, 2003
Submitter PLUS Orthopedics 6055 Lusk Blvd San Diego, CA
AUG - 8 2003
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Total knee
Classification name
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (per 21 CFR section 888.3560)
Equivalent Device
The VKS/TC-PLUS Revision Knee is equivalent to the VKS Total Knee (K022204) in terms of materials, articulating surface geometry, constraint and indications, and the RT-PLUS Modular Knee (K023667) in terms of modular stems and augmentation blocks.
Device Description
The VKS/TC-PLUS Revision Knee is a tri-compartmental knee consisting of a femoral component, tibial baseplate, tibial insert, femoral and tibial augmentation blocks and intramedullary stems.
The VKS/TC-PLUS Revision femoral component is available in five size and right and left configurations. It has a post in the box into which is machined a female Morse type taper to receive an intramedullary stem. It is also configured to received posterior and distal augmentation blocks.
The VKS/TC-PLUS Revision tibial baseplate has five sizes, right and left, and has the same outer profile as the VKS baseplates cleared in K022204. The tibial insert locking mechanism is the VKS Knee. The inferior surface of the baseplate has a short post with a female type taper machined into it to receive modular stems and a hole through the baseplate to receive a screw to augment the baseplate/stem connection. The stems are as used on the femoral component. The inferior surface of the baseplate also has two fins that extend posterior/laterally from the post.
The same ultra-congruent insert cleared with the VKS Knee under K022204 is used with the VKS/TC-PLUS Revision Knee.
The femoral augmentation blocks are available in distal and posterior configurations, 5mm and 10mm thickness. The tibial augmentation blocks are available in half blocks so that medial, lateral or full augmentation can be achieved. They are also available in 5mm and 10mm thickness.
Intended Use
The VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision knee arthroplasty where the collateral ligaments are indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tuma, infection, or connective tissue disorders. It is for cemented use only.
Summary of Technological Characteristics Compared to Predicate Device
Engineering analysis indicates that the VKS/TC-PLUS Revision Knee is as strong as its predicate devices.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol consisting of three stylized human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
PLUS Orthopedics c/o Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd Round Rock, TX 78681
Re: K032215
Trade/Device Name: VKS/TC-PLUS Revision Knee Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: July 17, 2003 Received: July 21, 2003
Dear Mr. Webb:
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 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.
2
Page 2 - Mr. J.D. Webb
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for 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
510(k) number (if known):
Device Name: VKS/TC-PLUS Revision Knee
Indications for Use:
VKS/TC-PLUS Revision Knee Indications for Use
VKS/TC-PLUS Revision Knee is intended for use in patients who are candidates for revision k nee a rthroplasty w here the collateral ligaments a re intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, or connective tissue disorders. It is for cemented use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO322215
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