Exactech® Truliant™ Line Extensions

K171045 · Exactech, Inc. · JWH · Apr 28, 2017 · Orthopedic

Device Facts

• Record ID: K171045
• Device Name: Exactech® Truliant™ Line Extensions
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 28, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present. The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.

Device Story

Truliant line extensions consist of femoral components, tibial inserts, and tibial trays for tricompartmental total knee arthroplasty. Devices are modular components used to resurface femoral and tibial bone. Implantation performed by orthopedic surgeons in clinical/OR settings. Devices function as semi-constrained cemented prostheses. Modifications are limited to dimensional changes to existing product lines (K170240, K152170). Output is a physical implant system replacing damaged joint surfaces to restore function and reduce pain.

Clinical Evidence

Bench testing only. Evaluated mechanical patellofemoral constraint, patellofemoral contact pressure, insert/tray assembly micromotion, insert/tray locking strength, and biocompatibility. Pyrogen testing performed per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Semi-constrained cemented knee prosthesis (polymer/metal/polymer). Modular design. Materials and construction identical to predicate devices. Sterilization per FDA guidance for sterile devices.

Indications for Use

Indicated for skeletally mature individuals undergoing primary total knee replacement or revision of failed reconstructions due to osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions, provided sufficient bone stock and soft tissue integrity exist. Cemented use only.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Exactech Truliant Femoral Components (K170240)
• Exactech One Logic Tibial Assembly (K152170)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

Exactech. Inc. Patrick Hughes Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K171045

Trade/Device Name: Exactech® Truliant™ Line Extensions Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: April 6, 2017 Received: April 7, 2017

Dear Mr. Hughes:

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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Vincent J. Devlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171045

Device Name Exactech® Truliant™ Line Extensions

#### Indications for Use (Describe)

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span>☑</span><span> Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐</span><span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## Exactech® Truliant™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness

| <b>Sponsor:</b> | Exactech, Inc.<br>2320 N.W. 66th Court<br>Gainesville, FL 32653 |
|-----------------|-----------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | FDA Establishment Number 1038671 |
| <b>Contact:</b> | Patrick Hughes<br>Senior Regulatory Affairs Specialist |

Date: April 6, 2017

Trade or Proprietary or Model Name(s): Exactech® Truliant™ Line Extensions

Common Name: Cemented Total Knee Prosthesis

Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code: JWH

Classification Panel: Orthopedic

Regulation Number 888.3560

Device Class II

#### Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---------------|--------------------------------------|---------------|
| K170240 | Exactech Truliant Femoral Components | Exactech, Inc |
| K152170 | Exactech One Logic Tibial Assembly | Exactech, Inc |

## Indications for Use:

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-

{4}------------------------------------------------

## Exactech® Truliant™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness

traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only.

## Device Description:

Truliant femoral components are for use in resurfacing femoral bone as part of tricompartmental total knee arthroplasty employing modular components from the Optetrak / Optetrak Logic and Truliant device families.

Proposed Truliant femoral components represent modifications to Truliant femoral components cleared per 510(k) K170240. The proposed Truliant femoral components are identical to cited predicate femoral components except for dimensional modifications representing new additions to the product scope.

Proposed Truliant tibial trays represent modifications to One Logic tibial trays cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant trays are identical to cited predicate trays except for dimensional modifications representing new additions to the product scope.

Proposed Truliant tibial inserts represent modifications to One Logic tibial inserts cleared per 510(k) K152170 and rebranded as Truliant per 510(k) K170240. The proposed Truliant inserts are identical to cited predicate inserts except for dimensional modifications representing new additions to the product scope.

The proposed devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction. are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.

{5}------------------------------------------------

## Exactech® Truliant™ Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness

## Testing Description:

This submission references results for mechanical patellofemoral constraint, patellofemoral contact pressure testing, mechanical insert / tray assembly micromotion, mechanical insert / tray locking strength, and device biocompatibility. Results conclude the proposed Truliant devices do not represent a new worst-case for risks associated with patellofemoral contact, insert / tray assembly properties, or biocompatibility.

Pyrogen testing was conducted in accordance with USP <161>. USP <85>, and ANSI/AAMI ST72 to ensure the proposed Truliant components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.

## Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate proposed Truliant line extensions are substantially equivalent to cited cleared predicate Truliant femoral components and One Logic / Truliant tibial inserts and tibial trays.