(84 days)
Not Found
No
The document describes a mechanical knee implant system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are bench testing and engineering analyses of the physical device properties.
Yes
The device is a knee arthroplasty system, which is intended for the treatment of non-inflammatory degenerative joint disease, indicating a therapeutic purpose to alleviate symptoms or restore function.
No
Explanation: The device is a TGS® Unicompartmental Knee Arthroplasty Modular Tibia System, which is an implantable knee arthroplasty system intended for surgical use, not for diagnosing conditions.
No
The device description clearly states the device is a two-piece construction including a tibial baseplate made of titanium alloy and a tibial insert made of ultra-high molecular weight polyethylene. These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "arthroplasty of either condyle of a knee." This is a surgical procedure involving the replacement of a joint.
- Device Description: The description details a physical implant (tibial baseplate and insert) designed to be surgically placed in the knee.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a surgical implant used for joint replacement, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
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
TGS® Unicompartmental Knee Arthroplasty Modular Tibia System (Modular Tibia) is designed to be used with the TGS® Unicompartmental Knee Arthroplasty System (K090024). The Modular Tibia is designed as a two piece construction including a tibial baseplate and a (poly) tibial insert. The tibial baseplate is composed of titanium alloy and is provided in six sizes. The tibial baseplate is indicated for cemented use only. The tibial insert is composed of ultra-high molecular weight polyethylene and is provided in six sizes corresponding to each metal baseplate size. Each tibial insert size is provided in four thicknesses. The tibial insert assembles to a corresponding tibial baseplate with a snap-fit lock mechanism. The Modular Tibia is provided in right and left configurations for use in the medial or lateral tibiofemoral compartment of the knee. The Modular Tibia is packaged sterile with each tibial baseplate and each tibial insert packaged individually.
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:
The following bench testing and analysis has been performed to demonstrate that the TGS UKA Modular Tibia presented no new risks and is substantially equivalent to the predicate devices:
- Bench testing of the modular component interlock of subject and predicate devices.
- Engineering analysis of strength and fatigue properties of subject and predicate devices.
- Engineering analysis of range of motion and contact area/stress of subject and predicate devices.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the subject device, the Modular Tibia, to the indicated 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.
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
K101206 # '1/3
Alexandria Research Technologies, LLC
Traditional 510(k) Premarket Notification TGS® UKA Modular Tibia
2 510(k) Summary
Date Prepared: April 27, 2010
General Information
Submitter's Name / Contact Person
Manufacturer
| Alexandria Research Technologies, LLC |
|---|
| 13755 First Ave. North, Suite 100 |
| Plymouth, Minnesota 55441 |
JUL 2 3 2010
Contact Person
Michael Larson RA/QA Manager Office : 952-949-2235 Fax : 952-949-2007 Email : mikel(@art-orthopaedics.com
| Proprietary Name | TGS® Unicompartmental Knee Arthroplasty Modular Tibia
System |
|---------------------|----------------------------------------------------------------------------------------------------------|
| Common Name | Compartmental Knee Prosthesis System |
| Classification Name | CFR 21 888.3520 Knee joint femorotibial metal/polymer non-
constrained cemented prosthesis, Class II |
| | CFR 21 888.3530 Knee joint femorotibial metal/polymer semi-
constrained cemented prosthesis, Class II |
| Product Device Code | HSX, HRY |
| Predicate Devices | DePuy Preservation ™ Unicondylar Tibia (K040268, Cleared: May
5, 2004) |
| | Genesis Unicompartmental Knee System (Accuris), Smith &
Nephew (K912735, Cleared: December 27, 1991) |
| | TGS® Unicompartmental Knee Arthroplasty System (K090024,
Cleared: May 4, 2009) |
Device Description
TGS® Unicompartmental Knee Arthroplasty Modular Tibia System (Modular Tibia) is designed to be used with the TGS® Unicompartmental Knee Arthroplasty System (K090024). The Modular Tibia is designed as a two piece construction including a tibial baseplate and a (poly) tibial insert. The tibial baseplate is composed of titanium alloy and is provided in six sizes. The tibial baseplate is indicated for cemented use only. The tibial insert is composed of ultra-high molecular weight polyethylene and is provided in six sizes corresponding to each metal baseplate size. Each tibial insert size is provided in four thicknesses. The tibial insert assembles to a corresponding tibial baseplate with a snap-fit lock mechanism. The Modular Tibia is provided in right and left configurations for use in the medial or lateral tibiofemoral compartment of the knee. The Modular Tibia is packaged sterile with each tibial baseplate and each tibial insert packaged individually.
1
K101206 # 2/3
Alexandria Research Technologies, LLC
| Subject Device | Predicate #1 | Predicate #2 | Predicate #3 | |
|---|---|---|---|---|
| TGS ® UKA Modular | ||||
| Tibia System | DePuy Preservation | |||
| (K040268) | Smith & Nephew | |||
| Genesis (Accuris) | ||||
| (K912735) | TGS ® UKA | |||
| System (K090024) | ||||
| Tibial Insert | ||||
| Material | UHMWPE | UHMWPE | UHMWPE | UHMWPE |
| Interface | Anterior/Posterior snap fit | Anterior/Posterior snap fit | Medial/Lateral snap fit | N/A |
| Thickness | ||||
| (Combined) | 8, 9, 10 & 11 mm | 9.5, 11.5 & 13.5mm | 8, 9, 10,11 & 12mm | 7, 8, 9, 10 & 11mm |
| Sizes | 40, 44, 48, 52, 56, 60mm A/P | 41, 45, 49, 53, 57mm A/P | 38.0, 41.7, 45.6, 48.8, | |
| 52.3, 55.4mm A/P | 40, 44, 48, 52, 56, | |||
| 60mm A/P | ||||
| Sterilization | Ethylene Oxide Sterilization | Gamma Sterilization | N/A | Ethylene Oxide |
| Sterilization | ||||
| Packaging | Sterile devices are packaged in | |||
| Double Barrier Thermoform | ||||
| Trays (PETG) with Tyvek Lids | Sterile devices are | |||
| packaged in GVF Foil | ||||
| Packaging with outer Poly | ||||
| Pouch. | N/A | Sterile devices are | ||
| packaged in Double | ||||
| Barrier Thermoform | ||||
| Trays with Tyvek Lids | ||||
| Tibial Baseplate | ||||
| Material | Titanium | CoCr | Titanium | |
| Fixation | 1) Double contoured pegs, |
- Single A/P keel. Contact
surface has cement pockets.
Cement fixation. | Keel with cement pocket | Post , Keel and Cement
Pocket | |
| Baseplate
Thickness | 2mm | 2mm | 2mm | |
| Sizes | 40, 44, 48, 52, 56, 60mm A/P | 41, 45, 49, 53, 57mm A/P | 38.0, 41.7, 45.6, 48.8,
52.3, 55.4mm A/P | |
| Sterilization | Ethylene Oxide | Gamma Sterilization | N/A | |
| Packaging | Sterile devices are packaged in
Double Barrier Thermoform
Trays with Tyvek Lids | Sterile devices are
packaged in Double Barrier
Thermoform Trays with
Tyvek Lids | N/A | |
Comparison of Subject to Predicate
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. 2.
- 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.
2
K101208 #3/3
Alexandria Research Technologies, LLC
Substantial Equivalence Discussion
The indications for use, principles of operation, materials, sizes, type of interface, fixation, packaging, and sterilization of the Modular Tibia are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the Modular Tibia is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification.
Non-Clinical Testing
The following bench testing and analysis has been performed to demonstrate that the TGS UKA Modular Tibia presented no new risks and is substantially equivalent to the predicate devices:
- Bench testing of the modular component interlock of subject and predicate devices. .
- Engineering analysis of strength and fatigue properties of subject and predicate devices. .
- . Engineering analysis of range of motion and contact area/stress of subject and predicate devices
Clinical Testing
Clinical testing was not necessary to demonstrate substantial equivalence of the subject device, the Modular Tibia, to the indicated predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The text is in all caps.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alexandria Research Technologies, LLC % Michael Larson RA/QA Manager 13755 First Avenue North, Suite 100 Plymouth, Minnesota 554411
JUL 2:3 2010
Re: K101206
Trade/Device Name: TGS® UKA Modular Tibia System 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 28, 2010 Received: May 03, 2010
Dear Mr. Larson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Mr. Michael Larson
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Millesen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K101206
Device Name: TGS® UKA Modular Tibia System
INDICATIONS
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. 2.
-
- 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.
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)
Onetti for mkm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101206