OSTEOCURE RESORBABLE BEAD KIT

K051406 · Nexa Orthopedics, Inc. · MQV · Aug 1, 2005 · Orthopedic

Device Facts

• Record ID: K051406
• Device Name: OSTEOCURE RESORBABLE BEAD KIT
• Applicant: Nexa Orthopedics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process. OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.

Device Story

OsteoCure Resorbable Bead Kit and Injectable Graft Kit consist of premeasured surgical grade calcium sulfate powder and mixing solution. Physician mixes components into paste; paste injected or packed into bone voids/gaps or molded into beads. Cures in-situ to form radiopaque, biodegradable scaffold. Used in surgical settings to fill osseous defects; can augment provisional hardware like K-wires. Resorbs in 30-60 days, replaced by natural bone. Benefits patient by providing temporary scaffold for bone healing in non-load bearing sites.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Surgical grade calcium sulfate bone void filler. Provided as kit with powder and mixing solution. Cures in-situ to form radiopaque, biodegradable paste or molded beads. Sterile, single-use. Non-load bearing.

Indications for Use

Indicated for patients with non-load bearing bone voids or gaps in the skeletal system (long bones, extremities, spine, pelvis) resulting from surgery or trauma. May be used at infected sites. Not for structural support.

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

• Biogeneration, ProFusion Bone Graft Substitute Kits (K031838, K973704)
• Wright Medical (K010532, K024336)

Submission Summary (Full Text)

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K051406

# AUG 1 - 2005

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

| Prepared: | May 26, 2005 |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Applicant: | Futura Biomedical<br>990 Park Center Drive<br>Vista, CA 92081 |
| Telephone: | 760-599-1670 |
| Fax: | 760-599-1675 |
| Contact: | Louise M. Focht |
| Device Name: | Filler, Bone Void, Calcium Compound |
| Device Trade Name: | OsteoCure Resorbable Bead Kit<br>Osteo Cure Injectable Graft Kit |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 21 CFR 888.3045 |
| Product Code: | 87 MQV |
| Predicate Device: | Biogeneration, ProFusion Bone Graft<br>Substitute Kits, K031838, K973704,<br>Wright Medical K010532, K024336 |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |

## Device Description:

OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit consist of premeasured surgical grade calcium sulfate, pre-measured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OsteoCure Kits produce biodegradable, radiopaque paste/molded beads that resorb in approximately 30-60 days, when used according to labeling.

After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

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K051406

## Materials:

The materials used for the OsteoCure Kits are substantially equivalent to Biogeneration, Profusion Bone Graft Substitute Kit and Wright Medical OsteoSet.

## Indications for Use:

The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

OsteoCure paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.

OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.

### Comparison to Predicate Device:

Technological Characteristics:

The OsteoCure Kits have the equivalent chemical composition and the technological characteristics as the predicate device.

### Performance data:

Testing demonstrated that the performance of the OsteoCure Kits are substantially equivalent to the performance of the predicate device.

### Summary:

The intended use, material composition, and design features of the OsteoCure Injectable Graft Kit paste cured in situ and OsteoCure Resorbable Bead Kits are substantially equivalent to the intended use, material composition and design features of the predicate device.

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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 curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 - 2005

Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92081

Re: K051406

Trade/Device Name: OsteoCure Resorbable Bead Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device. Regulatory Class: II Product Code: MQV Dated: May 26, 2005 Received: May 31, 2005

Dear Ms. Focht:

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 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.

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Page 2 - Ms. Louise M. Focht

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 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,

Stipt Ruvola

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): | K051406 |
|---------------------------|--------------------------------|
| Device Name: | Osteo Cure Resorbable Bead Kit |
| Indications for Use: | |

The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.

OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.

Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUATION ON OTHER PAGE OF NEEDED)
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices

**510(k) Number**

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