OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS

K132161 · Exactech, Inc. · JWH · Oct 11, 2013 · Orthopedic

Device Facts

• Record ID: K132161
• Device Name: OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OPTETRAK Comprehensive Knee Systems 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 revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

Device Story

The Optetrak Logic 17mm & 19mm Thick Inserts are UHMWPE tibial components designed for use in total knee arthroplasty (TKA). These inserts serve as an extension to the existing 9mm-15mm range, compatible with both posterior-stabilized (PS, PSC) and cruciate-retaining (CR, CRC) Optetrak Logic systems. The device is implanted by orthopedic surgeons during TKA procedures, functioning as the articulating surface between metal femoral components and tibial trays. The primary purpose is to provide additional thickness options to accommodate patient-specific anatomical needs during primary or revision surgery. The device is intended for cemented fixation. Clinical benefit is derived from restoring joint function and stability in patients with degenerative knee conditions.

Clinical Evidence

Bench testing only. The submission relied on engineering studies, specifically locking stability testing (anterior/posterior liftoff/dissociation), to demonstrate substantial equivalence to the predicate devices.

Technological Characteristics

Material: UHMWPE per ASTM F648. Design: Tibial insert components for TKA, compatible with metal femoral components and tibial trays. Sterilization: Gamma radiation to a sterility assurance level of 10^-6. Shelf life: 8 years. No software or electronic components.

Indications for Use

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

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

• Optetrak Logic PS (K093360)
• Optetrak Logic PSC (K110547)
• Optetrak Logic CR (K111400)
• Optetrak Logic CR Sizes 0 & 6 (K121307)
• Optetrak Logic CRC (K123342)
• Exactech Cemented Total Knee System Tibial Components (K933610)
• Optetrak Cruciate Retaining Tibial Components (K932776)

Submission Summary (Full Text)

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# Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Traditional 510(k) - 510(k) Summary

Exactech, Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653

> Phone: [phone] [phone] Fax:

FDA Establishment Number 1038671

Contact: Patrick Hughes Senior Regulatory Affairs Specialist

Date: July 10. 2013

**OCT** 1 1 2013

Trade of Proprietary or Model Name(s): Exactech Optetrak Logic 17mm & 19mm Thick Inserts

## Common Name:

Total Knee Arthroplasty - Tibial Inserts

#### Classification Name:

Cemented total knee prosthesis (CFR 888.3560, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Class II, Product Code JWH)

# Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------|----------------------------------------------------------|----------------|
| K093360 | Optetrak Logic PS | Exactech, Inc. |
| K110547 | Optetrak Logic PSC | Exactech, Inc. |
| K111400 | Optetrak Logic CR | Exactech, Inc. |
| K121307 | Optetrak Logic CR Sizes 0 & 6 | Exactech, Inc. |
| K123342 | Optetrak Logic CRC | Exactech, Inc. |
| K933610 | Exactech Cemented Total Knee System<br>Tibial Components | Exactech, Inc. |
| K932776 | Optetrak Cruciate Retaining Tibial<br>Components | Exactech, Inc. |

# Indications for Use:

The OPTETRAK Comprehensive Knee Systems 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 revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

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# K132161

# Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Traditional 510(k) - 510(k) Summary

# Device Description:

The proposed Optetrak Logic 17mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UHMWPE) tibial insert components cleared per 510(k)s K093360. K110547. K111400. K121307, and K123342.

This submission proposes adding 17mm and 19mm tibial insert options to the existing 9mm-15mm range of Optetrak Logic insert thicknesses. The 17mm and 19mm thick inserts will be provided across the current component size range (size 0 through size 6). Like the predicate devices, the proposed inserts are used in total knee arthroplasty (TKA) with metal femoral components and tibial trays. The thicker inserts are proposed for both posterior-stabilized (Logic PS, Logic PSC) and cruciate-retaining (Logic CR. Logic CRC) product options.

### Comparison of Technological Characteristics

The predicate and proposed devices have the same intended use and basic fundamental scientific technology. The intended use of the modified device, as described in the labeling, has not changed as a result of the proposed modifications. The modified devices share the following similarities with the predicate devices:

- . Indications for use
- Design features (including mating geometry, locking mechanism, and . articulating geometry)
- . Material (UHMWPE per ASTM F648)
- o 8-year shelf life
- o Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10th
- . Use at the same site in the body for the same purpose (TKA)

The proposed components are not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

# Non-Clinical Performance Data

Table 1 shows non-clinical performance data provided, cited, or referenced in this submission to support a conclusion of substantial equivalence:

#### Table 1: Optetrak Logic 17mm & 19mm Thick Tibial Inserts Testing

| Evaluation | Activity |
|-------------------|-------------------------------------------------|
| Locking stability | Anterior/posterior liftoff/dissociation testing |

# Substantial Equivalence Conclusion:

Comparison analysis and results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic 17mm Thick Tibial Inserts are substantially equivalent to predicate Optetrak Logic tibial inserts cleared per 510(k)s K093360, K110547, K111400, K121307. K123342, K933610, and K932776.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

October 11, 2013

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653

Re: K132161

Trade/Device Name: Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts 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: September 19, 2013 Received: September 20, 2013

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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#### Page 2 - Mr. Patrick Hughes

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincercly yours.

# Erin Keith

िर

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

Enclosure

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# Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Special 510(k) - Indications for Use

510(k) Number: K132161

Device Name: Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts

# INDICATIONS

The OPTETRAK Comprehensive Knee Systems 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 revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

Prescription Use_ ど (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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