OSTEOFIX BONE VOID FILLER

{0}------------------------------------------------ ### 510(k) SUMMARY ## CALCITEC, INC. OSTEOFIX™ BONE VOID FILLER APR 1 2 2007 # Sponsor's Name, Address, Telephone Number, Contact Person and Date Prepared Calcitec, Inc 7000 Bee Cave Road Suite 250 Austin, TX 78746 Phone: 512-306-9555 Facsimile: 512-306-9557 Contact Person: Brooke Campbell Date Prepared: January 23, 2007 #### Name of Device Osteofix™ Bone Void Filler #### Common or Usual Name Bone Void Filler, Bone Void Filler #### Classification Name Class II Classification: Classification Name: Filler, bone void, calcium compound #### Predicate Devices - Interpore Cross International, Pro Osteon 500R (K990131) . - Berkelev Advanced Biomaterials, Inc., Cem-Ostetic (K040405) ● - Synthes, Norian SRS Bone Void Filler (K011897) ● #### Intended Use / Indications for Use Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a Bone Void Filler that resorbs and is replaced with bone during the પ્રધ્યમ {1}------------------------------------------------ ### aling process. chaological Characteristics eofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Fil ﺍﻟﻤﻌﻠﺎﺓ Calcina ) ﺃﻥ ﻣﺴﻠﺴﻞ ﺍﻟﻤﺸﺎﻫﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺪ # Performance Data e performance of Osteofix™ has been compared to Pro Osteon 500R in a si nparison study. Results demonstrated substantially similar rates of resorpt aterial. sults of bench testing demonstrate that Osteofix™ Bone Void Filler meets its specifications I does not raise new issues of safety or effectiveness. In all instances, Osteofi ler functioned as intended. #### compatibility Data led for permanent blood contacting devices, and the materials w ocompatible. Additionally, the same materials are commonly used in similar medic # stantial Equivalence <™ Bone Void Filler is substantially equivalent to the predicate devices. Osted iller has the same intended uses and similar indications, technological istics, and principles of operation as its predicate devices. The minor technol Terences between Osteofix™ Bone Void Filler and its predicate devices raise no new issues of Tely or effectiveness. Performance data demonstrate that Osteofix™ Bone Void Fi \$\frac{2}{2}\$ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. 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 Calcitec, Inc. % Ms. Brooke Campbell, Esq. Vice President. Clinical and Regulatory Affairs 7000 Bee Cave Road, Suite 250 Austin, Texas 78746 APR 1 2 2007 Re: K070220 Trade Name: Osteofix™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class: II Product Code: MQV Dated: April 5, 2007 Received: April 5, 2007 Dear Ms. Campbell: 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. {3}------------------------------------------------ Page 2 – Ms. Brooke Campbell, Esq. This letter will allow you to begin marketing your device as described in your Section 510(k) I his lotter will anon you vo be on finding of substantial equivalence of your device to a legally promatted 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 (240) 276-0120. 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 other gollers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Barbara Buehno Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Statement K070220 510(k) Number (if known): Device Name: Osteofix™ Bone Void Filler Indications for Use: Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a Bone Void Filler that resorbs and is replaced with bone during the healing process. Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Darhare Buechnp Page **_ of _** Division of General, Restorative, and Neurological Devices Ko 20220 510(k) Number . 12