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.

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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on various characteristics, implying that if the device is substantially equivalent, it meets the necessary performance for market clearance. The comparison table below highlights the key characteristics reviewed.

Feature / Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (TGS® UKA Modular Tibia System)
Tibial Insert Material	UHMWPE	UHMWPE
Tibial Insert Interface	Anterior/Posterior or Medial/Lateral snap fit	Anterior/Posterior snap fit
Tibial Insert Thickness	Similar range to predicates	8, 9, 10 & 11 mm
Tibial Insert Sizes	Similar range to predicates	40, 44, 48, 52, 56, 60mm A/P
Tibial Baseplate Material	Titanium or CoCr	Titanium
Tibial Baseplate Fixation	Double contoured pegs, keel, cement pockets	1) Double contoured pegs, 2) Single A/P keel. Contact surface has cement pockets. Cement fixation.
Tibial Baseplate Thickness	2mm	2mm
Sterilization Method	Ethylene Oxide or Gamma Sterilization	Ethylene Oxide Sterilization
Packaging	Double Barrier Thermoform Trays with Tyvek Lids or similar	Sterile devices are packaged in Double Barrier Thermoform Trays (PETG) with Tyvek Lids
Indications for Use	Consistent with predicate devices	Non-inflammatory degenerative joint disease, failed previous implant, correctable deformity, cemented use only, single use as a system.
Bench Testing	No new risks compared to predicates	Modular component interlock, strength & fatigue properties, range of motion & contact area/stress demonstrated to present no new risks.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify a "test set" in the context of clinical or large-scale performance testing with human data. The assessment for this device appears to rely on non-clinical bench testing and engineering analysis comparing it to predicate devices. Therefore, the concept of a "test set" with a specific sample size for device performance against ground truth (as might be seen in diagnostic AI) is not applicable here.
Data Provenance: The data provenance is from non-clinical bench testing and engineering analysis conducted by Alexandria Research Technologies, LLC as part of its premarket notification to the FDA. The country of origin for the data generation would be the USA (Plymouth, Minnesota), where the company is located. The nature of the data is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve human expert adjudication for establishing ground truth as it is a medical device for knee arthroplasty, not a diagnostic or AI algorithm. The "ground truth" equivalent would be established engineering principles, material science standards, and performance characteristics of legally marketed predicate devices.

4. Adjudication Method

Not applicable as there is no human adjudication process described for establishing "ground truth" to evaluate a diagnostic device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned as this device is a physical implant, not a diagnostic tool where human readers interact with AI.

6. Standalone Performance (Algorithm Only)

Not applicable as this device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on engineering and materials standards, mechanical testing results, and the established safety and effectiveness of legally marketed predicate devices. The goal was to demonstrate substantial equivalence to these predicates, meaning the device performs as intended and presents no new risks.

8. Sample Size for the Training Set

Not applicable. There is no AI or algorithm involved that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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 TibiaSystem
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: May5, 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

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K101206 # 2/3

Alexandria Research Technologies, LLC

	Subject Device	Predicate #1	Predicate #2	Predicate #3
	TGS ® UKA ModularTibia System	DePuy Preservation(K040268)	Smith & NephewGenesis (Accuris)(K912735)	TGS ® UKASystem (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 OxideSterilization
Packaging	Sterile devices are packaged inDouble Barrier ThermoformTrays (PETG) with Tyvek Lids	Sterile devices arepackaged in GVF FoilPackaging with outer PolyPouch.	N/A	Sterile devices arepackaged in DoubleBarrier ThermoformTrays with Tyvek Lids
	Tibial Baseplate
Material	Titanium	CoCr	Titanium
Fixation	1) Double contoured pegs,2) Single A/P keel. Contactsurface has cement pockets.Cement fixation.	Keel with cement pocket	Post , Keel and CementPocket
BaseplateThickness	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 inDouble Barrier ThermoformTrays with Tyvek Lids	Sterile devices arepackaged in Double BarrierThermoform Trays withTyvek 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:

1. 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.
1. Components of this system are designed for single use and to be used as a system.

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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.

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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

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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

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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:

1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
Failed previous implant. 2.
1. Correctable deformity.
1. All TGS® UKA System implants are intended for cemented use only.
1. 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

Regulation Number and Section

§ 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.