(351 days)
Not Found
No
The device description focuses on the materials, components, and sizes of a knee implant system, with no mention of software, algorithms, or AI/ML capabilities. The performance studies mentioned are biomechanical testing, not related to AI/ML performance metrics.
Yes
The device is a knee system intended for use in treating degenerative arthritis and other destructive conditions of the knee joint. This directly addresses the treatment of a disease or injury.
No
The device, a Unicondylar Knee System, is intended for the treatment of knee conditions like degenerative arthritis and osteonecrosis, not for diagnosing them. It is a prosthetic implant, not a diagnostic tool.
No
The device description clearly states it consists of physical components (femoral and tibial components made of cobalt chrome and UHMWPE) and is intended for surgical implantation, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The UC-PLUS Solution Unicondylar Knee System is a surgical implant designed to replace parts of the knee joint. It is made of materials like cobalt chrome and UHMWPE and is intended to be surgically implanted into the body.
- Intended Use: The intended use describes treating conditions within the knee joint itself, not analyzing samples taken from the body.
Therefore, based on the provided information, the UC-PLUS Solution Unicondylar Knee System is a surgical device/implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The UC-PLUS Solution Unicondylar Knee System is intended for use in unicompartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium unicompartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic unicompartmental bone and/or cartilage lesions. For use with bone cement only.
Product codes
HRY
Device Description
The UC-PLUS Solution Unicondylar Knee System consists of a femoral component and a tibial component. The femoral component is made of a cobalt chrome cast alloy and is 4mm thick. Symetrical components can be used with right or left. The cement pockets are continuous for a minimal cement thickness of 1mm. The femoral component is available in 5 sizes. The tibial component has a flat articulating surface which provides more flexibility. The all-poly tibial component is made of UHMWPE. A cemented metal back tibial component is also available, made of cobalt chrome cast alloy and a UHMWPE insert. Both tibial components come in 5 sizes, 4 thicknesses each. All materials conform to ASTM standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
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)
Biomechanical Testing has been provided.
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
510(k) Summary of Safety and Effectiveness
August 14, 1998
UC-PLUS Solution Unicondylar Knee System Trade name:
Knee Joint Prosthesis Common name:
Knee Joint Femorotibial Metal/Polymer Semi-Constrained Cemented Classification name: Prosthesis (21 CFR 888.3530, 87HRY)
Sigma Uni-Compartmental Knee System P.F.C. (Johnson હિ Equivalence: Johnson), K954481, SE date 10/10/96
The UC-PLUS Solution Unicondylar Knee System consists of a Characteristics: femoral component and a tibial component. The femoral component is made of a cobalt chrome cast alloy and is 4mm thick. Symetrical components can be used with right or left. The cement pockets are continuous for a minimal cement thickness of 1mm. The femoral component is available in 5 sizes. The tibial component has a flat articulating surface which provides more flexibility. The all-poly tibial component is made of UHMWPE. A cemented metal back tibial component is also available, made of cobalt chrome cast alloy and a UHMWPE insert. Both tibial components come in 5 sizes, 4 thicknesses each. All materials conform to ASTM standards.
The UC-PLUS Solution Unicondylar Knee System is intended for use Indications: in unicompartmental degenerative arthritis. local osteonecrosis of the femoral condyle. light to medium unicompartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic unicompartmental bone and/or cartilage lesions. For use with bone cement only.
Contraindications: Contraindications include acute or chronic infections (local or systemic) 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.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Hartmut Loch Chief Executive Officer PLUS Orthopedics 3550 General Atomics Court, Bldg. 15-100 San Diego, California 92121-1122
K982859 Trade Name: UC-Plus Solution Unicondylar Knee System Regulatory Class: II Product Code: HRY Dated: May 4, 1999 Received: May 5, 1999
Dear Mr. Loch:
Re:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Mr. Hartmut Loch
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: UC-PLUS Solution Unicondylar Knee System
Indications for Use:
The UC-PLUS Solution Unicondylar Knee System is intended for use in unicompartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium unicompartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic unicompartmental bone and/or cartilage lesions. 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)
[signature]
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982859
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)