SYNTHES (USA) CHRONOS-BETA-TCP

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a circle with a design inside. To the right of the word is a small circle with an R inside, which is a registered trademark symbol. The word "SYNTHES" is likely the name of a company or product. ## JAN 2 3 2006 ## 3.0 510(k) Summary Page Page 1 of of 2 - Sponsor: Synthes (USA) 1302 Wrights Lane East West Chester, PA 19380 (610) 719-5000 Device Name: Synthes (USA) chronOS™ - B-TCP Classification: Class II, 21 CFR 8872.3930 Bone grafting material, synthetic Class II, 21 CFR §880.5600 Piston Syringe Predicate Device: Interpore IP 200 Coralline Hydroxyapatite Granules and Blocks chronOS, Craniofacial Applications, GXP Device Description: Synthes chronOS is a porous, osteoconductive, resorbable dental bone grafting material made from ß-Tricalcium Phosphate (TCP). chronOS features a uniform three dimensional pore structure. Pore diameters within the material range from 100 to 500 µm. chronOS is provided sterile in granules and preformed shapes (e.g. blocks, cylinders, wedges). chronOS may be packaged with a perfusion syringe that is used to mix the bone grafting material with the patient's blood, bone marrow or saline. Intended Use: Synthes chronOS is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosscous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filling of cystic defects; filling of extraction sites; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors, cysts or other osseous defects; and substitute for autogenous or allogenic bone grafts. Synthes chronOS is intended to be gently packed or placed into the site and may be combined with autogenous blood, bone marrow or saline. chronOS resorbs and is replaced with bone during the healing process. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. A small, circled "R" symbol is located to the right of the word, indicating that it is a registered trademark. Page __________ of ___________________________________________________________________________________________________________________________________________________________ Substantial Documentation is provided which demonstrates that Synthes chronOS Equivalence: is substantially equivalent* to other legally marketed Synthes devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance. Public Health Service SEP 1 3 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380 Re: K053022 Trade/Device Name: Synthes (USA) chronOS - B-TCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 29, 2005 Received: January 3, 2006 Dear Ms. Musgnung: This letter corrects our substantially equivalent letter of January 23, 2006. 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 (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 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. {3}------------------------------------------------ Page 2 - Ms. Musgnung Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basetains. mean that FDA has made a determination that your device complies with opension meall that PDA nas made a deceminations administered by other Federal agencies. of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally rederal statues and regurements, including, but not limited to: registration You must comply with an the Act 8 required (21 CFR Part 801); good manufacturing practices (200); and and listing (21 CFR Part 807), laceling (21 CFR Pat 820), and if 1 CFR Pat 820); and if requirents as set form in the quality by steams (2) steams (2) - ) - (2 of the Act); applicable, the electronic product radiation control provisions (sections 531-542 of the 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section This letter will anow you to continue many of substantial equivalence of your device to 510(k) premarket nonfleated. 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) 276-0115 (http://www.fda.gov/cdrh/organiz.html#0C for OC organization structure). Also, please (http://www.raa.gov.rounnels.gov.ding by reference to premarket notification" (21 CFR hout the regulation entitled, "There general information on your responsibilities under the r at 807.77). Tou may obtain only generers, International and Consumer Assistance at its Act from the DrAbient (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Signature Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A horizontal line runs beneath the word, and a small circle with a dot inside is located to the right of the letter "S". ## Indications for Use | 510(k) Number (if known): | | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Synthes (USA) chronOST™ - β-TCP | | Indications: | Synthes chronOS is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endondontic origin; filling of cystic defects; filling of extraction sites; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors, cysts or other osseous defects; and substitute for autogenous or allogenic bone grafts.<br>Synthes chronOS is intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline. chronOS resorbs and is replaced with bone during the healing process. | Prescription Use _____________________________________________________________________________________________________________________________________________________________ X ----(Per 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 (ODF) ty, Ceneral Hospi Coad, Demal Devices K05302 -5-