OSTEOPORE TCP

K062496 · Spinecraft, Inc. · MQV · Oct 19, 2006 · Orthopedic

Device Facts

• Record ID: K062496
• Device Name: OSTEOPORE TCP
• Applicant: Spinecraft, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoPore TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) 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. OsteoPore TCP should be gently packed into the defect/void without under filling or over filling. OsteoPore TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Story

OsteoPore TCP is a synthetic, resorbable calcium phosphate bone void filler; functions as an osteoconductive scaffold to support bone formation. Device features interconnected porosity (60-80%) with pore sizes 200-500um; available in various shapes/sizes. Intended for surgical implantation by physicians to fill non-structural osseous defects; material resorbs and is replaced by host bone during healing. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Synthetic resorbable calcium phosphate bone void filler; porous scaffold structure; interconnected porosity 60-80%; pore size 200-500um. No energy source, software, or electronic components.

Indications for Use

Indicated for filling non-structural bone voids or defects in the skeletal system, including extremities, spine, and pelvis, resulting from surgery or traumatic injury.

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

• Kasios TCP (K042340)

Submission Summary (Full Text)

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### VII. 510(k) Summarv

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

# A. Submitted by

SpineCraft, Inc. 2215 Enterprise Drive Suite 1504 Westchester, IL 60154 Telephone: [phone] Date Prepared: August 21, 2006.

#### B. Device Name

Trade or Proprietary Name: OsteoPore TCP Common or Usual Name: Bone Void Filler Classification Name: Unclassified

# C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared device Kasios TCP (K042340).

#### D. Device Description

The OSTEOPORE TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.

#### E. Intended Use

OSTEOPORE TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) 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. OSTEOPORE TCP should be gently packed into the defect/void without under filling or over filling. OSTEOPORE TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.

#### F. Substantial Equivalence

Data was provided which demonstrated the OSTEOPORE TCP to be substantially equivalent to the previously cleared device. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 9 2006

SpineCraft, Incorporated c/o Ms. Ami Akallal-Asaad Regulatory Affairs Manager 2215 Enterprise Drive, Suite 1504 Westchester, Illinois 60154

Re: K062496

> Trade/Device Name: Osteopore TCP Regulation Number: 21 CFR §888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: October 6, 2006 Received: October 10, 2006

Dear Ms. Akallal-Asaad:

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.

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Page 2 - Ms. Akallal-Asaad

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. 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.

Kula Palang

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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# A. Indications for Use

510(k) Number (if known): K062496

Device Name: OsteoPore TCP

Indications for Use:

OsteoPore TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) 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. OsteoPore TCP should be gently packed into the defect/void without under-filling or over-filling. OsteoPore TCP is a Jonne graft substitute that resorbs and is replaced with bone during the healing process.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

510(k) Number_