OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++

K082022 · Exactech, Inc. · JWH · Sep 2, 2008 · Orthopedic

Device Facts

• Record ID: K082022
• Device Name: OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 2, 2008
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

Ultra high molecular weight polyethylene tibial insert; component of Optetrak Comprehensive Knee System. Device features +6° posterior angle to enable surgeon adjustment of tibial slope and PCL function intraoperatively without additional bone cuts. Used in orthopedic surgery for total knee replacement. Compatible with existing Optetrak femoral, tibial, and patellar components. Surgeon-operated; provides mechanical stability and alignment correction for patient benefit.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Ultra high molecular weight polyethylene tibial insert; +6° posterior angle; semi-constrained design; compatible with existing Optetrak system components.

Indications for Use

Indicated for skeletally mature individuals undergoing primary total knee replacement for osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions; also indicated for revision of failed reconstructions with sufficient bone stock and soft tissue integrity.

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® Cruciate Retaining Cemented Total Knee System (K932690)

Submission Summary (Full Text)

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# Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++ Special 510(k) - Summary of Safety and Effectiveness

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

SEP - 2 2008

Phone: (352) - 377 - 1140 Fax: (352) - 378 - 2617

FDA Establishment Number 1038671

Contact: Graham Cuthbert Regulatory Representative

Date: June 25, 2008

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## Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++ Special 510(k) - Summary of Safety and Effectiveness

## Trade or proprietary or model name(s):

Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++

#### Common Name

Cruciate Retaining Tibial Insert

#### Classification name

Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal polymer (21 CFR Section 888.3560)

# Information on devices to which substantial equivalence is claimed:

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|------------------------------------------------------------|----------------|
| K932690 | Optetrak® Cruciate Retaining Cemented Total Knee<br>System | 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.

### Device Description:

The proposed Optetrak CR Slope 9mm ++ devices are ultra high molecular weight polyethylene tibial inserts intended to enable surgeons to adjust tibial slope, and therefore PCL function, at the end of a procedure without the need for additional bone cuts. The proposed devices are made from the same materials as the predicated devices. There the also compatible with the same femoral, tibial and patellar components as the cleared predicate devices. The only difference between devices is a +6° posterior angle built into the Optetrak CR Slope 9mm ++ tibial inserts.

## Substantial Equivalency Conclusion:

Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP - 2 2008

Exactech. Inc. % Mr. Graham Cuthbert Regulatory Representative 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K082022

Trade/Device Name: Exactech Optetrak® 9 mm Cruciate Retaining Tibial Insert Slope ++ 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: August 20, 2008 Received: August 21, 2008

Dear Mr. Cuthbert:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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#### Page 2 - Mr. Graham Cuthbert

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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

Enclosure

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# Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++ Special 510(k) - Indications for Use

K082022 510(k) Number:

Device Name: Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++

## 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.

Prescription Use X and/or Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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)

Soubau Buemo

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082022