OPTECURE +CCC

K061668 · Exactech, Inc. · MBP · Sep 12, 2006 · Orthopedic

Device Facts

• Record ID: K061668
• Device Name: OPTECURE +CCC
• Applicant: Exactech, Inc.
• Product Code: MBP · Orthopedic
• Decision Date: Sep 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OpteCure + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Thesper of ent may be surgically created osseous defects or osseous defects created from to autonatic injury to the bone. OpteCure may be used with rigid fixation systems.

Device Story

Optecure™ + CCC is a bone graft kit containing polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), and mixing solution. The clinician mixes the components to create a putty, which is then manually placed into bone voids or gaps in the extremities, spine, or pelvis. The device acts as a scaffold that gradually resorbs and is replaced by new bone during the healing process. It is intended for use by surgeons in an operating room setting. The device provides a physical filler for osseous defects not intrinsic to skeletal stability and can be used in conjunction with rigid fixation systems to support bone repair.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including an in-vivo athymic mouse assay to assess osteoinductive potential of the DBM component and a viral reduction study using four virus models (RNA, DNA, envelope, and non-envelope) to validate the demineralization process.

Technological Characteristics

Kit-based bone void filler consisting of polymer powder, corticocancellous bone chips, and demineralized bone matrix. Resorbable calcium salt-based material. Manual mixing and application. No electronic components or software.

Indications for Use

Indicated for use as a bone graft extender (extremities, spine, pelvis) and bone void filler (extremities, pelvis) for non-structural bony voids or gaps resulting from surgery or traumatic injury. May be used with rigid fixation systems.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Optecure™ (K050806)
• Opteform® (K043421)
• Grafton® DBM (K051195)
• OrthoBlast® II (K050642)
• DBX® Demineralized Bone Matrix Mix (K040262)

Submission Summary (Full Text)

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2320 NW 66TH COURT GAINESVILLE, FL 32653

# Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

House stransmission in the

SEP 1 2 2006

352-377-1140 FAX [phone]

# Traditional 510(k) Summary of Safety and Effectiveness

This 510(k) Summary for Optecure™ + CCC is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

| Sponsor: | Exactech Inc.<br>2320 NW 66th Court<br>Gainesville, Florida 32653<br>Telephone [phone]<br>Fax [phone] |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FDA Establishment Number 1038671 |
| Contact: | Maritza Elias<br>Regulatory Representative<br>Exactech Inc.<br>2320 NW 66th Court<br>Gainesville, Florida<br>Telephone [phone]<br>Fax [phone] |
| Proprietary Name: | Optecure™ + CCC |
| Common Name: | Bone void filler, |
| Product Code: | MQV, MBP |
| Device Class: | Class II |
| Classification Name: | 21CFR §888.3045 Resorbable calcium salt<br>bone void filler device |
| Classification Panel: | Orthopedic |

Rev 06 07 06

Section 4 Page 1 of 3

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2320 NW 66TH COURT GAINESVILLE, FL 32653

Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

352-377-1140 FAX [phone]

## Traditional 510(k) Summary of Safety and Effectiveness

# Legally Marketed Devices for Substantial Equivalence Comparison:

| Product<br>Code | Manufacturer | 510(k) Number | Product |
|-----------------|-----------------------------------------|---------------|---------------------------------------|
| MQV, MBP | Exactech Inc. | K050806 | Optecure™ |
| MQV | Regeneration<br>Technologies | K043421 | Opteform® |
| MQV, MBP | Osteotech | K051195 | Grafton® DBM |
| MQV, MBP | IsoTis | K050642 | OrthoBlast® II |
| MQV, MBP | Muskuloskeletal<br>Tissue<br>Foundation | K040262 | DBX® Demineralized Bone<br>Matrix Mix |

Optecure™ + CCC is substantially equivalent to one or more of the 510(k) cleared predicate devices summarized in the above table in that they share similar design, material composition and function.

## Device Description:

Optecure™ + CCC is packaged in the form of a kit with pre-measured polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), premeasured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids.

Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.

## Indications:

Optecure™ + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Optecure™ + CCC may be used with rigid fixation systems.

Rev 06 07 06

Section 4 Page 2 of 3

#### A Great Day in the O.R.

EXACTECH exist to intraduals by maintining their a citivity and independere. We do this through increative iseas, high-quoting products, education and commitment to sence

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# Exactech®, Inc. Optecure™ + CCC Traditional 510(k)

2320 NW 66TH COURT GAINESVILLE, FL 32653

352-377-1140 FAX [phone]

# Traditional 510(k) Summary of Safety and Effectiveness

### Safety & Effectiveness Information

#### Ostcoinductive Potential a.

Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in-vivo athymic mouse assay. Findings from the animal model are not necessarily predictive of human clinical results.

#### b. Viral Inactivation Validation

A viral reduction study was conducted by a CLIA certified testing laboratory using four virus models representing RNA, DNA, envelope and non-envelope virus. This study demonstrates the demineralization process used on donor bone contained in Optecure™ + CCC significantly diminishes these model viruses and can reasonably be anticipated to diminish the titers of other viruses.

Rev 06 07 06

Section 4 Page 3 of 3

#### A Great Day in the O.R."

EXACTECH exist to inprove the quality of it in independent. We to the more interest increative increative idess, high-quility podect, aduction and commitment senses.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 2 2006

Exactech % Ms. Maritza Elias Regulatory Representative 2320 NW 66th Court Gainesville, FL 32653

Re: K061668

Trade/Device Name: Optecure™ +CCC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Codes: MBP, MQV Dated: June 7, 2006 Received: June 14, 2006

Dear Ms. Elias:

:

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 l'ederal 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 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);

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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 m 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), n you deente spee of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may bound band gallery, 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,

Barbaya Buckins

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

Enclosure

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# Exactech, Inc.® Optecure™ + CCC Traditional 510(k)

# Indications For Use

510(k) Number (if known):

## Indications for Use:

OpteCure + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Thesper of ent may be surgically created osseous defects or osseous defects created from to autonatic injury to the bone.

OpteCure may be used with rigid fixation systems.

Prescription Use

Over the Counter Use VANJAO.

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

Rev 05/30/06

**510(k) Number** K061668

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