OPTECURE

K050806 · Exactech, Inc. · MBP · Feb 8, 2006 · Orthopedic

Device Facts

• Record ID: K050806
• Device Name: OPTECURE
• Applicant: Exactech, Inc.
• Product Code: MBP · Orthopedic
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OpteCure 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 may be used with rigid fixation systems.

Device Story

OpteCure is a single-use, aseptic bone void filler kit containing pre-measured powder, demineralized bone matrix (DBM), and mixing solution. The clinician mixes the components to create a putty, which is then manually placed into skeletal bone voids or gaps. The device is intended for use in extremities, spine, and pelvis. It acts as a scaffold that gradually resorbs and is replaced by new bone during the healing process. It is designed for use in surgical settings to address osseous defects from trauma or surgery. The device is compatible with rigid fixation systems.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, viral inactivation validation using four virus models (RNA, DNA, envelope, and non-envelope), and in-vivo osteoinductivity testing using an athymic mouse assay.

Technological Characteristics

Resorbable bone void filler kit consisting of demineralized bone matrix (DBM) and a mixing solution. Supplied as an aseptic, single-use implantable device. Osteoinductive potential verified via in-vivo athymic mouse assay. Viral inactivation validated via laboratory testing.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, and pelvis) not intrinsic to structural stability, resulting from surgical creation or traumatic injury. Used as a bone graft extender or void filler. 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

• Exactech Resorbable Bone Paste (K040755)
• Regenafil Allograft Paste, Regenafil RT Paste, Osteofil Optefil, RTI Allograft Paste (K043420)
• MBCP (K043005)
• Allomatrix (K020895)

Submission Summary (Full Text)

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050806

## FEB 8 2006

# Traditional 510(k) Summary of Safety and Effectiveness

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

| 1. | Submitter: | Exactech Inc.<br>2320 NW 66th Court<br>Gainesville, Florida 32653<br>Telephone [phone]<br>Fax [phone] |
|----|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact person: | Maritza Elias<br>Regulatory Representative<br>Exactech Inc.<br>2320 NW 66th Court<br>Gainesville, Florida<br>Telephone [phone]<br>Fax [phone] |
| | Date of original 510k submission: | March 27, 2005 |
| | Date of follow-up information | November 7, 2005 |
| | FDA Establishment Number | 1038671 |
| 2. | Proprietary Name: | OpteCure |
| | Common Name: | Bone void filler |
| | Product Code: | MQV, MBP |
| | Device Class: | Class II |
| | Classification Name: | 21CFR §888.3045 Resorbable calcium<br>salt bone void filler device |
| | Classification Panel: | Orthopaedic |

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# Traditional 510(k) Summary of Safety and Effectiveness

### Legally Marketed Devices for Substantial Equivalence Comparison: 3.

| Product Code | Manufacturer | 510(k)<br>Number | Product |
|--------------|----------------------------------|------------------|--------------------------------------------------------------------------------------------|
| MQV, MBP | Exactech Inc. | K040755 | Exactech Resorbable Bone<br>Paste |
| MQV | Regeneration<br>Technologies Inc | K043420 | Regenafil Allograft Paste,<br>Regenafil RT Paste, Osteofil<br>Optefil, RTI Allograft Paste |
| MQV | Biomatlante | K043005 | MBCP |
| MQV | Wright Medical<br>Technologies | K020895 | Allomatrix |

### Comparison to the Predicate Device(s): 4.

OpteCure is the substantially equivalent to the predicate devices.

### ડ. Device Description:

OpteCure comes in the form of a kit with pre-measured powder and demineralized bone matrix (DBM), pre-measured 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. Supplied as aseptic manufacture, single use, ready to mix implantable device derived from a single donor.

OpteCure gradually resorbs and is replaced with new bone during the healing process.

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

### Indications for Use 6.

OpteCure 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 may be used with rigid fixation systems.

### 7. Safety & Effectiveness Information

### Osteoinductive Potential થ.

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 Opte Cure significantly diminishes these model viruses and can reasonably be anticipated to diminish the titers of other viruses.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 8

Ms. Maritza Elias Regulatory Affairs Representative Exactech Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K050806

OpteCure Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: November 8, 2005 Received: November 10, 2005

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 the Federal F 60d, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an 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 (1 var 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 Eederal 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.

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Page 2 -- Ms. Maritza Elias

You must comply with all the Act's requirements, including, but not limited to: registration 1 od inton compry with and 1979; 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); 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 Office 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 maj count of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

2

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

Enclosure

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## Indications for Use

510(k) Number (if known):

K050806

OpteCure Device Name:

Indications for Use:

OpteCure 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 may be used with rigid fixation systems.

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|---------------------------------------------------|--------|------------------------------------------------|
|---------------------------------------------------|--------|------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | K050806 |
|---------------|---------|
|---------------|---------|

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