TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM

K101206 · Alexandria Research Technologies, LLC · HSX · Jul 23, 2010 · Orthopedic

Device Facts

• Record ID: K101206
• Device Name: TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
• Applicant: Alexandria Research Technologies, LLC
• Product Code: HSX · Orthopedic
• Decision Date: Jul 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 2. Failed previous implant. 3. Correctable deformity. 4. All TGS® UKA System implants are intended for cemented use only. 5. Components of this system are designed for single use and to be used as a system.

Device Story

Modular tibial component for TGS Unicompartmental Knee Arthroplasty System; consists of titanium alloy baseplate and UHMWPE tibial insert. Insert attaches to baseplate via snap-fit lock mechanism. Used in medial or lateral tibiofemoral compartments. Implanted by orthopedic surgeons in clinical/OR settings. Provides articulating surface for knee joint; replaces damaged cartilage/bone. Benefits patients by restoring joint function and reducing pain associated with degenerative disease. Single-use, sterile, cemented fixation.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing only, including modular component interlock testing, engineering analysis of strength and fatigue properties, and analysis of range of motion and contact area/stress.

Technological Characteristics

Modular tibial prosthesis; titanium alloy baseplate, UHMWPE insert. Snap-fit locking mechanism. Six sizes (40-60mm A/P). Cemented fixation. Ethylene oxide sterilization. Standalone orthopedic implant.

Indications for Use

Indicated for patients requiring arthroplasty of either knee condyle due to non-inflammatory degenerative joint disease (osteoarthritis, post-traumatic arthritis), failed previous implants, or correctable deformity. Intended for cemented use only.

Regulatory Classification

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).

Predicate Devices

• DePuy Preservation ™ Unicondylar Tibia (K040268)
• Genesis Unicompartmental Knee System (Accuris), Smith & Nephew (K912735)
• TGS® Unicompartmental Knee Arthroplasty System (K090024)

Submission Summary (Full Text)

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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 : [phone] Email : mikel(@art-orthopaedics.com

| Proprietary Name | TGS® Unicompartmental Knee Arthroplasty Modular Tibia<br>System |
|---------------------|----------------------------------------------------------------------------------------------------------|
| Common Name | Compartmental Knee Prosthesis System |
| Classification Name | CFR 21 888.3520 Knee joint femorotibial metal/polymer non-<br>constrained cemented prosthesis, Class II |
| | CFR 21 888.3530 Knee joint femorotibial metal/polymer semi-<br>constrained cemented prosthesis, Class II |
| Product Device Code | HSX, HRY |
| Predicate Devices | DePuy Preservation ™ Unicondylar Tibia (K040268, Cleared: May<br>5, 2004) |
| | Genesis Unicompartmental Knee System (Accuris), Smith &<br>Nephew (K912735, Cleared: December 27, 1991) |
| | TGS® Unicompartmental Knee Arthroplasty System (K090024,<br>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.

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K101206 # 2/3

Alexandria Research Technologies, LLC

| | Subject Device | Predicate #1 | Predicate #2 | Predicate #3 |
|-------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------|
| | TGS ® UKA Modular<br>Tibia System | DePuy Preservation<br>(K040268) | Smith & Nephew<br>Genesis (Accuris)<br>(K912735) | TGS ® UKA<br>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<br>(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,<br>52.3, 55.4mm A/P | 40, 44, 48, 52, 56,<br>60mm A/P |
| Sterilization | Ethylene Oxide Sterilization | Gamma Sterilization | N/A | Ethylene Oxide<br>Sterilization |
| Packaging | Sterile devices are packaged in<br>Double Barrier Thermoform<br>Trays (PETG) with Tyvek Lids | Sterile devices are<br>packaged in GVF Foil<br>Packaging with outer Poly<br>Pouch. | N/A | Sterile devices are<br>packaged in Double<br>Barrier Thermoform<br>Trays with Tyvek Lids |
| | Tibial Baseplate | | | |
| Material | Titanium | CoCr | Titanium | |
| Fixation | 1) Double contoured pegs,<br>2) Single A/P keel. Contact<br>surface has cement pockets.<br>Cement fixation. | Keel with cement pocket | Post , Keel and Cement<br>Pocket | |
| Baseplate<br>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,<br>52.3, 55.4mm A/P | |
| Sterilization | Ethylene Oxide | Gamma Sterilization | N/A | |
| Packaging | Sterile devices are packaged in<br>Double Barrier Thermoform<br>Trays with Tyvek Lids | Sterile devices are<br>packaged in Double Barrier<br>Thermoform Trays with<br>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:

- 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.
- 5. 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 [phone] or [phone] 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.
- 3. Correctable deformity.
- 4. All TGS® UKA System implants are intended for cemented use only.
- 5. 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