(119 days)
Not Found
No
The summary describes a traditional knee implant system made of standard materials and components, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is a knee arthroplasty system intended to treat degenerative joint disease, which directly addresses a medical condition or ailment.
No
The device is a knee arthroplasty system, which is a prosthetic implant used for surgical replacement of part of the knee joint. It is not used to diagnose a medical condition but rather to treat it.
No
The device description explicitly states the system is composed of physical components made of cobalt-chromium alloy and polyethylene, which are hardware implants.
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 TGS Unicompartmental Knee Arthroplasty System is a surgical implant designed to replace a portion of the knee joint. It is made of materials like cobalt-chromium alloy and polyethylene and is surgically implanted into the body.
- Intended Use: The intended use is for arthroplasty (joint replacement surgery) of the knee. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgically implanted device used for treatment, not a device used for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:
-
- Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
-
- Failed previous implant.
-
- Correctable deformity.
-
- All TGS® UKA System implants are intended for cemented use only.
Components of this system are designed for single use and to be used as a system.
Product codes (comma separated list FDA assigned to the subject device)
HSX, HRY
Device Description
The TGS® UKA System is composed of unicompartmental femoral components and unicompartmental tibial components. These components may be used in various combinations to create a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee. TGS® UK A System components include individually packaged femoral components made of cobalt-chromium allov and all-poly tibial components of ultra-high molecular weight polyethylene with radiographic markers. The femoral components are available in 6 symmetrical sizes for medial or lateral application in right or left knees. The tibial components are available in two sets of 6 sizes; one set for right-medial or leftlateral tibial plateau, and one set for right-lateral or left-medial tibial plateau. Each tibial component size is available in 5 thicknesses with cither flat or contoured articular surface, and with either two contoured pegs or anterior-posterior (A/P) keel cement/bone fixation features.
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)
Non-Clinical Testing: Engineering analysis was performed to demonstrate that the TGS® UKA System implant components presented no new risks and are substantially equivalent to the predicate devices.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence between the subject TGS® UKA System implant components and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K010810 DePuy Orthopaedics Preservation Unicondylar Knee Prosthesis, K012591 Wright Medical Technology ADVANCE® Unicondylar Knee System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K090024
2 510(k) Summary
Date Prepared: January 2, 2009
Submitter's Name / Contact Person
Manufacturer
Alexandria Research Technologics, LLC 13755 First Ave. North, Suite 100 Plymouth, Minnesota 55441
Contact Person
Mike Renner Vice President Operations Office : 952-949-2235 Fax : 952-949-2007 Email : miker@art-orthopaedics.com
General Information
| Proprietary Name | TGS® Unicompartmental Knee Arthroplasty System (TGS® UKA
System) |
|---------------------|----------------------------------------------------------------------------------------------------------|
| Common Name | Compartmental Knee Prosthesis System |
| Classification Name | CFR 21 888.3520 Knee joint femorotibial metal/polymer non-
constrained cemented prosthesis, Class II |
| Classification Name | CFR 21 888.3530 Knee joint femorotibial metal/polymer semi-
constrained cemented prosthesis, Class II |
| Product Device Code | HSX, HRY |
| Predicate Devices | K010810 DePuy Orthopaedics Preservation Unicondylar Knee
Prosthesis |
| Predicate Devices | K012591 Wright Medical Technology ADVANCE® Unicondylar
Knee System |
Device Description
The TGS® UKA System is composed of unicompartmental femoral components and unicompartmental tibial components. These components may be used in various combinations to create a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee. TGS® UK A System components include individually packaged femoral components made of cobalt-chromium allov and all-poly tibial components of ultra-high molecular weight polyethylene with radiographic markers. The femoral components are available in 6 symmetrical sizes for medial or lateral application in right or left knees. The tibial components are available in two sets of 6 sizes; one set for right-medial or leftlateral tibial plateau, and one set for right-lateral or left-medial tibial plateau. Each tibial component size is available in 5 thicknesses with cither flat or contoured articular surface, and with either two contoured pegs or anterior-posterior (A/P) keel cement/bone fixation features.
1
K090024 *2/2
Indications for Use
The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:
-
- Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
-
- Failed previous implant.
-
- Correctable deformity.
-
- All TGS® UKA System implants are intended for cemented use only.
Components of this system are designed for single use and to be used as a system.
Substantial Equivalence Discussion
The indications for use, principles of operation, materials, sizes, type of interface, fixation, packaging, and sterility of the TGS® UKA System components are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of TGS® UKA System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification.
Non-Clinical Testing
Engineering analysis was performed to demonstrate that the TGS® UKA System implant components presented no new risks and are substantially equivalent to the predicate devices.
Clinical Testing
Clinical testing was not necessary to demonstrate substantial equivalence between the subject TGS® UKA System implant components and the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black.
Public Health Service
MAY - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alexandria Research Technologies, LLC % Mr. Michael Renner 13755 First Avenue North, Suite 100 Plymouth, Minnesota 55441
Re: K090024
Trade/Device Name: TGS Unicompartmental Knee Arthroplasty Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX, HRY Dated: April 16, 2009 Received: April 17, 2009
Dear Mr. Renner:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Michael Renner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.
Sincerely yours,
Barbarabonehms
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K050024
Device Name: TGS® Unicompartmental Knee Arthroplasty System
Indications for Use:
The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of a knee with the following indications:
- Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis. l.
-
- Failed previous implant.
- Correctable deformity 3.
- All TGS® UKA System implants are intended for cemented use only. 4.
Components of this system are designed for single use and to be used as a system.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
· (Posted November 13, 2003)
Smita
(Division Sign. Off)
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icion Sional Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090024