THERIGRAFT TCP PUTTY BONE VOID FILLER

{0}------------------------------------------------ THERICS, LLC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-0255 FAX: E-MAIL: therics(@therics.com JAN 3 ] 2006 THERICS HEFERENG SPREFIALISTS ### 510(k) SUMMARY ## Therics' TheriGraft™ Bone Void Filler ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared ### Submitter's Name: #### Sunil Saini 609.514.7200 x7262 or 609.514.7200 (main) Telephone: Facsimile: 609.514.0255 Contact Person: Sunil Saini Date Prepared: November 1, 2005 ## Name of Device and Name/Address of Sponsor # TRADE/PROPRIETARY NAME OF DEVICE: TheriGraft™ TCP Putty Bone Void Filler #### ADDRESS: 115 Campus Drive Princeton, New Jersey 08540 #### Common or Usual Name: Bone Void Filler. Synthetic Bone Void Filler. Synthetic Cancellous Bone Void Filler. Bone Graft Substitute. Synthetic Bone Substitute. Synthetic Cancellous Bone Substitute. #### Classification Name Bone Void Filler #### Predicate Device Orthovita's Vitoss™ {1}------------------------------------------------ THERICS, L.L.C. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 FAX: FAX: --------------------------------------------------------------------------------------------------------------------------------------------------------------------609-514-0255 E-MAIL: therics@therics.com Image /page/1/Figure/1 description: The image shows the logo for THERICS. The logo features a stylized letter "T" made of plus signs. Below the "T" is the word "THERICS" in a stylized font, and below that are the words "ENGINEERING SPECIALISTS" in a smaller font. ## Intended Use / Indications for Use TheriGraft™ TCP Putty Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone. ## Technological Characteristics and Substantial Equivalence The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier. Pre-clinical performance testing conducted on TheriGraft™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reation, bone ingrowth, residual material, and mechanical testing. TheriGraft™ bone void filler has the same intended use and indications, the same or similar principles of overation and technological characteristics, and equivalent performance in an appropriate animal model. Therefore, TheriGraff™ Bone Void Filler is substantially equivalent to the predicate device (see Table 1). Attachment - 6 Page 3 of 4 {2}------------------------------------------------ THERICS, LLC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 FAX: 609-514-0255 E-MAIL: therics@therics.com Image /page/2/Picture/1 description: The image shows the logo for "THERICS". The logo consists of a stylized letter "T" made up of plus signs, with the word "THERICS" written in a blocky, sans-serif font below it. Underneath the company name are the words "TISSUE ENGINEERING SPECIALISTS" in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name and area of expertise. | Characteristics<br>or Attributes | TheriGraft™<br>(NEW) | Vitoss ™<br>K994337 | Comments | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Indications for Use | Indicated for use in filling<br>the gaps or voids of osseous<br>defects surgically created or<br>resulting from trauma.<br>TheriGraft™ may be used<br>with autogenous bone<br>marrow | Indicated for use in filling<br>the gaps or voids of osseous<br>defects surgically created or<br>resulting from trauma.<br>Vitoss may be used with<br>autogenous bone marrow | Same | | Intended Use | Intended for treatment of<br>osseous defects not intrinsic<br>to the stability of the bone<br>structure. The product is<br>intended for use in defects of<br>the skeletal system (i.e., the<br>extremities, spine and<br>pelvis). | Intended for treatment of<br>osseous defects not intrinsic<br>to the stability of the bone<br>structure. The product is<br>intended for use in defects<br>of the skeletal system (i.e.,<br>the extremities, spine and<br>pelvis). | Same. | | Labeling | See Indications for Use and<br>Intended Use. | See Indications for Use and<br>Intended Use. | SE. | | Target Population | Patients with osseous defects<br>surgically created or<br>resulting from trauma. | Patients with osseous<br>defects surgically created or<br>resulting from trauma. | Same. | | Design | Porous trabecular structures<br>similar to cancellous bone.<br>Approximately 0.1 – 0.4 mm<br>granules. | Porous trabecular structures<br>similar to cancellous bone.<br>1 – 4 mm granules. | Similar internal structures for<br>TheriGraft & Vitoss.<br>Granule dimensions are<br>different. | | Materials | Calcium salt; β-tricalcium<br>phosphate mineral phase in<br>poloxamer carrier. | Calcium salt; β-tricalcium<br>phosphate mineral phase. | Same. | | Performance | Pre-clinical study to<br>demonstrate performance<br>characteristics. | Pre-clinical study to<br>demonstrate performance<br>characteristics. | SE. | | Sterility | Gamma irradiation. | Gamma irradiation. | Same. | | Biocompatibility | Product tested according to<br>ISO 10993, Biological<br>Evaluation of Medical<br>Devices. | Unknown. | Same. | | Chemical Safety | Product tested according to<br>ISO 10993, Biological<br>Evaluation of Medical<br>Devices. | Unknown. | Same. | | Anatomical Sites | Osseous defects not intrinsic<br>to the stability of the bone<br>structure. | Osseous defects not intrinsic<br>to the stability of the bone<br>structure. | Same. | | Where Used:<br>Hospital, home,<br>ambulance, etc. | Hospital or Health Care<br>Practitioner’s surgical suite. | Hospital or Health Care<br>Practitioner’s surgical suite. | Same. | | Design Control | Design Controls:<br>Verification & Validation | Unknown. | SE. | # Table 1: TheriGraft™ & Vitoss™ SE and Comparison Chart {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo for a company called "THERICS'." The logo features a stylized letter "T" formed by a series of plus signs. Below the company name, there is some text that is difficult to read due to the image quality, but it appears to say "TISSUE ENGINEERING SPECIALISTS." # CONFIDENTIAL ## Attachment - 12 ### Indications for Use Form 510(k) Number (if known): Not assigned at this time Device Name: TheriGraft™ TCP Putty Bone Void Filler Indications for Use: TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e., the extremities, spine and pelvis). TheriGrafTM parts create a network within the defect site that resorbs during healing and is replaced by bone # (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 C.F.R. 801.109) OR Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 1 2006 Sunil Saini, Ph.D. Director, Biomaterials THERICS, LLC. 115 Campus Drive Princeton, New Jersey 08540 Re: K053228 Trade/Device Name: TheriGraft™ TCP Putty Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: November 16, 2005 Received: November 21, 2005 Dear Dr. Saini: 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 sct 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. {5}------------------------------------------------ Page 2 -- Sunil Saini, Ph.D. 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 (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, sincerely yours, Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): Ko5 3228 # Device Name:_Therigraft™ TCP Putty Bone Void Filler Indications For Use: TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone. 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-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Signature KOS3228 Page 1 of 1