(29 days)
No
The summary describes a knee implant with mechanical components and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for partial replacement of articulating surfaces of the knee due to degenerative disease or fractures, which indicates a therapeutic purpose to restore function and alleviate symptoms.
No
The device is described as an implantable prosthetic used for partial replacement of knee articulating surfaces, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (tibial inserts and baseplates made of UHMWPE and CoCr alloy) intended for surgical implantation, indicating it is a hardware medical device.
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 partial replacement of knee articulating surfaces. This is a device used in vivo (within the body) during a surgical procedure.
- Device Description: The device components are described as tibial inserts and baseplates made from materials like UHMWPE and CoCr alloy, designed for implantation with bone cement. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
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 additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the Uni Knee cleared in K020741.
The tibial inserts of this submission are the similar the tibial components in K020741 with the addition of a snap feature on the non-articulating side. This snap feature is meant to be used with the tibial baseplate. The tibial inserts are manufactured from UHMWPE that conforms to ASTM F648 and are available in 5 sizes (35-45 mm) and 3 thicknesses (6-8 mm).
The tibial baseplates are manufactured from CoCr alloy that conforms to ASTM F75 and are available in 5 sizes (35-45 mm) and 2 configurations (left medial/right lateral and right medial/left lateral).
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)
K020741, K971938, K980665, K010810, K012591
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
022437
page 1 of 1
510(k) Summary of Safety and Effectiveness
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(1) Submitter's name: Submitt_r'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 July 23, 2002 -
(2) Uni Knee Trade or proprietarv device name: Common or usual name: Knee system Classification name: Class II
-
(3) Predicate devices:
Encore Uni Knee (K020741) Biomet Repicci II (K971938, K980665) DePuy Preservation (K010810) Wright Advance (K012591)
(4) Subject device description:
The additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the Uni Knee cleared in K020741.
The tibial inserts of this submission are the similar the tibial components in K020741 with the addition of a snap feature on the non-articulating side. This snap feature is meant to be used with the tibial baseplate. The tibial inserts are manufactured from UHMWPE that conforms to ASTM F648 and are available in 5 sizes (35-45 mm) and 3 thicknesses (6-8 mm).
The tibial baseplates are manufactured from CoCr alloy that conforms to ASTM F75 and are available in 5 sizes (35-45 mm) and 2 configurations (left medial/right lateral and right medial/left lateral).
(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.
Basis for Substantial Equivalence: (6)
The Uni Knee additional components are similar in design, materials and indications to the Encore Uni Knee cleared in K020741.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2002
Ms. Joanna Droege Regulatory/QA Engineer Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758
Re: K022437
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: July 23, 2002 Received: July 25, 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,
A. Mark A. Mellecker
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): | KO2026 |
|---|---|
| --------------------------- | -------- |
): RV2273/
Device Name:
Uni Knee Additional Components
Indications For Use:
Uni Knee Indications For Use
Intended for partial replacement of the articulating surfaces of the only one side of the joint is affected due to compartmental primage or post-traumatic degenerative disease, previous tibial congress or fractures, deformity or revision of previous arthroplasty. The device use implant intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Weaver
(Division Sign-Off)
Division of General, Recorative and Neurological Devices
510(k) Number K022437
Prescription Use (per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)_
SKSO
OR
II