XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES

{0}------------------------------------------------ K070737 JUL 25 2007 ## 510K Summary of Safety & Effectiveness # Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories Company: Contact: Prosurg, Inc 2193 trade Zone blvd San Jose CA 95131 Ashvin Desai . Mgr Regulatory Affairs Tel: (408) 945 -4044 Date Preparaed: June 29, 2007 Device Name: XsorbTM Bioabsorbable Craniofacial Bone Fixation System & Accessories Predicated Devices: Synthes Craniofacial Plate and Screw System (Ref: # K050608) Inion CPS Baby 1.5 Bioabsorbable Fixation System ( Rf: # K051341) BONAMATES Series cleared by FDA (Ref:#K040650) #### Device Description: Xsorb™ Bicabsorbable Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable Bone Fixation plates, meshes, fixation screws, fastners and tacks designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable Bone fixation plates and meshes are offered in various sizes and configurations to meet anatomical needs of the patients. The Xsorb™ - Bioabsorbable Craniofacial Bone Fixation pltaes & screws / wires are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ) . The bone plates and meshes are designed to be used with 1.8mm screws and 2.1 mm emergency screws for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm screw driver. Indications for Use: ### General Indication for Use: Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children, #### Specific Indications for Use: - Fractures of the cranium, mid-face, maxilla and chin. - Infant craniofacial surgery (i.e. Craniosynostosis, Congenital malformations) . - Le Forte ( I, II, III ) Osteotomies. . {1}------------------------------------------------ K070737 - Pediatric Reconstructive procedures of Cranial facial Skeleton . - Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. ● - Facial Craniotomy flap fixation. ● # Comparison of technological Characteristics: Xsorb™- Bioabsorbable Craniofacial Bone Fixation System & Accessories for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and children are substantially equivalent to the predicated devices, Synthes Craniofacial Plate and Screw System, Inion CPS Saby 1.5 Bioabsorbable Fixation System, BONAMATES Series cleared by FDA under 510k application # K050608, 1.5 DKaborousers of the FDA regulatory clearance report, 510k application and product information details regarding predicated device is attached herewith for your review and consideration. Please mornation domin rogarding product specifications, Material compatibility and Indications for Use for the proposed device with predicated device. Please note that the proposed product is substantially equivalent to predicated devices in product design, materials, packaging and intended use. ### Performance Data: Preclinical testing was performed to ensure that the Xsorb™ - Bioabsorbable Craniofacial Bone Fixation System & I toomion results not performs as intended when used according to the instructions for use. Laboratory product testing has indicated that the Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories has demonstrated satisfactory performance for its intended applications. Mechanical testing of the devices also demonstrated that the tensile strength, breakage force and degradation time for the device are equal or more than the predicated devices and are satisfactory for its intended use. {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 lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL 2 5 2007 Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Incorporated 2193 Trade Zone Boulevard San Jose, California 95131 Re: K070737 Trade/Device Name: Xsorb™- Bioabsorbable Craniofacial Bone Fixation System & Accessories Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 29, 2007 Received: July 3, 2007 Dear Mr. Desai: 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. {3}------------------------------------------------ Page 2 - Mr. Desai 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 (240) 276-0115. 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 vours. Snytte Y. Michaud, Dmd. 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}------------------------------------------------ K070737 # Indications for Use ## 510(k) Number (if known). K070737 Device Name: Xsorb™ - Bioabsorbable Craniofacial Bone Fixation System & Accessories. Indications for Use: #### General Indication for Use: Xsorb™- Bioabsorbable Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and chin in adult and children. Specific Indications for Use: - Fractures of the cranium, mid-face, maxilla and chin. . - . Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations) - Le Forte ( I, II, III ) Osteotomies. . - Pediatric Reconstructive procedures of Cranial facial Skeleton. . - Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. . - Facial Craniotomy flap fixation. . Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) | |--------------------------------------------------------| |--------------------------------------------------------|  | (Division Sign-Off) | | |-----------------------------------------------|--------| | Division of Anesthesiology, General Hospital, | | | Infection Control, Dental Devices | | | 510(K) Number: | K07037 |