(153 days)
None
No
The 510(k) summary describes a mechanical knee replacement system made of standard materials (CoCr and UHMWPE) and does not mention any software, image processing, AI, ML, or related performance metrics.
Yes
The device is a knee replacement system used to treat degenerative diseases, which aligns with the definition of a therapeutic device.
No
The document describes a knee replacement system, which is a therapeutic device intended for replacing damaged knee components, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components made of Cobalt Chrome and UHMWPE, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Uniglide unicondylar knee replacement system is a physical implant designed to replace damaged parts of the knee joint. It is surgically implanted into the body.
- Intended Use: The intended use is to replace articulating surfaces of the knee due to degenerative disease or damage. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.
Product codes
HRY
Device Description
The device consists of Cobalt Chrome (CoCr) alloy femoral component which articulates against an ultra high molecular polyethylene (UHMWPE) tibial component.
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)
K042093, K980665, K954186, K982859
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
AUG 2 4 2005
510(k) Summary
Date:
3/1/05
Applicant Name:
Corin Group PLC The Corinium Centre Cirencester Gloucestershire GL7 1YJ United Kingdom
Richard Sharp Contact Person: Regulatory Affairs Director Corin Group PLC +44 1285 659866
Proprietary Name: Uniglide™ Unicondylar Knee Replacement System
Common Name: Unicompartmental knee replacement
Classification Name: Prosthesis, knee, femerotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.3530)
Class/Product Code: Class II / HRY
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Substantially Equivalent Devices: Vanguard M™ Series Unicondylar Tibial Bearings (K042093); Repicci II™ Unicondylar Knee (K980665); Link Endo-Model™ Sled Uniknee (K954186); UC Plus Solution Unicondylar Knee System (K982859)
Device Description: The device consists of Cobalt Chrome (CoCr) alloy femoral component which articulates against an ultra high molecular polyethylene (UHMWPE) tibial component.
Indications for Use: Replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee and is intended to be used with bone cement.
Basis for Substantial Equivalence: The sponsor claims substantial equivalence (SE) of the Uniglide Unicondylar Knee Replacement System to the previously approved Vanguard M series, Recippi II, Link Endo-Model Sled and UC Plus Solution unicondylar knees (see Table 1).
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
AUG 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel K. Batts Director, US Regulatory Affairs Corin U.S.A. 10500 University Center Drive Suite 190 Tampa, Florida 33612
Re: K050764
Trade/Device Name: Uniglide Unicondylar Knee Replacement 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: August 03, 2005 Received: August 05, 2005
Dear Mr. Sharp:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled is (c) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to may 20, 2017 accordance with the provisions of the Federal Food, Drug, de rices that have been recise approval of a premarket approval application (PMA). and Cosmete Ace (11et) that do nevice, subject to the general controls provisions of the Act. The r ou may, therefere, mains of the Act include requirements for annual registration, listing of general controls provision of the stative, 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 may be subject to sater additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I oderal statutes and states and mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, labeling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by stone (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Joel K. Batts
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your intial equivalence of your device to a legally premainct notification: "The PDF intember of the sification 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 If you desire specific advice 10. Jour 2011) 276-0120. Also, please note the regulation entitled, Colliation of Compullier in (21 CFR Part 807.97). You may obtain Missuranting of Telefono to premailsonibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson ಕ್ಕೆ ಕ Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): KOSO 764
Device Name: Uniglide Unicondylar Knee Replacement System
Indications for Use:
The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KO50 364 Concurrence of CDRH, Office of Device Evaluation (ODE)