(23 days)
Not Found
No
The document describes a mechanical knee implant and its components, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is a knee implant intended to treat degenerative joint diseases, which is a therapeutic application.
No
The provided text describes a knee implant system used for treating knee conditions, not for diagnosing them.
No
The device description clearly states that the device is a knee system consisting of physical components (femoral and tibial components) made of materials like CoCrMo alloy and polyethylene. It is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating conditions within the knee joint (degenerative arthritis, osteonecrosis, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a knee implant (femoral and tibial components). This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The device is used directly within the knee joint, which is consistent with a surgical implant.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used in vivo (within the body) as a replacement for damaged joint components.
N/A
Intended Use / Indications for Use
The UC-PLUS Solution Unicondylar Knee is intended for use in uni-compartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium uni-compartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic uni-compartmental bone and/or cartilage lesions. It is intended for use with bone cement only.
Product codes
HRY
Device Description
This knee system consists of a femoral component. The femoral component is fabricated from cast CoCrMo alloy (ASTM F79) and is 4mm thick. Symmetrical, the femoral components can be used on right or left knees. Cement pockets are cast into the components to provide a minimum 1mm cement mantle. The femoral component is available in four sizes.
The tibial component is manufactured from ultra-high molecular weight polyethylene. A cemented metal backed tibial component is also available. Both tibial components are available in five sizes and four thicknesses.
The subject of this Special 510(k) submission is the modification to the implant/bone interface of the femoral component and the elimination of the smallest size femoral component.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (uni-compartmental)
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)
Summary Nonclinical Tests: The change in fin height of the UC-PLUS Solution Unicondylar Knee femoral component resulted in no increased risks and decreased the stresses in the component due to fatigue loading.
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
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Date June 27, 2003
Submitter
PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121
Contact person J.D. Webb 1001 Oakwood Blvd
Round Rock, TX 78681 512-388-0199
Trade name UC-PLUS Solution Unicondylar Knee
Common name Unicondylar Knee
Classification name
Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/Polymer
888.3530 (per 21 CFR section)
Indications for Use
The UC-PLUS Solution Unicondylar K nee is intended for use in uni-compartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium uni-compartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic uni-compartmental bone and/or cartilage lesions. It is intended for use with bone cement only.
Equivalent Device
This modified component is equivalent to the previously cleared UC-PLUS Solution Unicondylar Knee (K982859) in terms of indications, usage and materials.
Device Description
This knee system consists of a femoral component. The femoral component is fabricated from cast CoCrMo alloy (ASTM F79) and is 4mm thick. Symmetrical, the femoral components can be used on right or left knees. Cement pockets are cast into the components to provide a minimum 1mm cement mantle. The femoral component is available in four sizes.
The tibial component is manufactured from ultra-high molecular weight polyethylene. A cemented metal backed tibial component is also available. Both tibial components are available in five sizes and four thicknesses.
The subject of this Special 510(k) submission is the modification to the implant/bone interface of the femoral component and the elimination of the smallest size femoral component.
Summary Nonclinical Tests
The change in fin height of the UC-PLUS Solution Unicondylar Knee femoral component resulted in no increased risks and decreased the stresses in the component due to fatigue loading.
JUL 25 2003
K032052
page 1 of 1
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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 stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2003
PLUS Orthopedics c/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032052
Trade/Device Name: UC-PLUS Solution Unicondylar Knee Regulation Numbers: 21 CFR 888.3530 Regulation Names: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: June 27, 2003 Received: July 2, 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.
Sincerely yours,
for Mark A. Milliman
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):__KO32052
Device Name: UC-PLUS Solution Unicondylar Knee
Indications for Use:
UC-PLUS Solution Unicondylar Knee Indications for Use
The UC-PLUS Solution Unicondylar Knee is intended for use in uni-compartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium uni-compartmental destruction of the knee joint due to idiopathic and posttraumatic degenerative arthritis, traumatic uni-compartmental bone and/or cartilage lesions.
It is intended for use with bone cement 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)
Mark A. Milliman
(Division Sign-Off)
Di ision of General, Restorative and Neurological Devices
510(k) Number K032052