(90 days)
Not Found
No
The summary 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 described as an implant intended for partial replacement of articulating surfaces of the knee in cases of degenerative or post-traumatic disease, which directly addresses a health condition or injury.
No
The device is described as an implantable knee replacement system, not a tool for diagnosing medical conditions. Its intended use is for partial replacement of knee articulating surfaces, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is comprised of physical components (femoral and tibial components made of CoCr alloy and UHMWPE) intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is an implant intended for partial replacement of articulating surfaces of the knee. It is a physical component (femoral and tibial) made of metal and plastic that is surgically implanted into the body.
- Intended Use: The intended use describes a surgical procedure to address knee joint issues, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
Product codes
HRY
Device Description
The Uni Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75. The femoral component is available in 4 sizes (S, M, L, XL) and provided in two configurations (left medial/right lateral and right medial/left lateral).
The Uni Knee System tibial components are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 4 sizes (29-37 mm) and 3 thicknesses (7-9 mm).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971938, K980665, K010810, K012591
Reference Device(s)
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
§ 888.3530 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.
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510(k) Summary of Safety and Effectiveness
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(1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Joanna Droege March 4, 2002 -
(2) Trade or proprietary device name: Uni Knee Common or usual name: Knee system Classification name: Class II
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Predicate devices: (3) Biomet Repicci II (K971938, K980665) DePuy Preservation (K010810) Wright Advance (K012591)
(4) Subject device description:
The Uni Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75. The femoral component is available in 4 sizes (S, M, L, XL) and provided in two configurations (left medial/right lateral and right medial/left lateral).
The Uni Knee System tibial components are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 4 sizes (29-37 mm) and 3 thicknesses (7-9 mm).
(5) Subject device intended use:
Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
(6) Basis for Substantial Equivalence:
The Uni Knee is similar in design, materials and indications to the Biomet Repicci II, DePuy Preservation and Wright Advance unicondylar knee systems.
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 an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 4 2002
Ms. Joanna Droege OA Engineer Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758
Re: K020741
Trade/Device Name: Uni Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: March 4, 2002 Received: March 6, 2002
Dear Ms. Droege:
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 - Ms. Joanna Droege
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,
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
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510(k) Number (if known):
Device Name: Uni Knee
Indications For Use:
Uni Knee Indications For Use
KO20741
Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter Use
{Optional Format 1-2-96}
(Optional Format
Styt Quorde
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K020741 510(k) Number_
51645
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