SYNTHES RESORBABLE CONTOURABLE MESH

{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 circular logo with a design inside. A small registered trademark symbol is located to the right of the word. K022844 ## 3.0 Summary of Safety and Effectiveness Information [510(k) Summary] | SUBMITTER: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 | JAN 07 2003 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | CONTACT: | Angela J. Silvestri<br>(610) 647-9700 ext. 7190 | | | DEVICE NAME: | Resorbable Contourable Mesh | | | CLASSIFICATION: | Class II, 21 CFR §872.4760: Bone Plate. | | | PREDICATE DEVICE: | Documentation was provided which demonstrated the Synthes Resorbable<br>Contourable Mesh to be substantially equivalent to other legally marketed<br>devices. | | | DEVICE DESCRIPTION: | Synthes Resorbable Contourable Mesh is a resorbable material sheet that<br>comes in various sizes and shapes in perforated patterns that allow for better<br>anatomical conformity. It is a part of the Synthes Resorbable Fixation<br>System and can be used with the screws, tacks, and instruments in that<br>system. | | | INTENDED USE: | Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and<br>Tacks), are intended for use in fracture repair and reconstructive procedures<br>of the craniofacial skeleton. | | | | In addition, Resorbable Meshes, Sheets, Screws, and Tacks may be used in<br>non-load bearing applications for maintaining the relative position of and/or<br>containing bony fragments, bone grafts (autograft or allograft) or bone graft<br>substitutes in reconstruction of the craniofacial or mandibular areas. | | | CONTRAINDICATIONS: | These devices are not intended for use in full load bearing applications,<br>such as the mandible, unless used in conjunction with traditional rigid<br>fixation. Synthes Resorbable Fixation System devices are not intended for<br>areas with active or latent infection or for patient conditions including<br>limited blood supply or insufficient quantity or quality of bone. These<br>devices are not intended for use in the spine. | | | MATERIAL: | Poly(L/DL-lactide) | | MATERIAL: Poly(L/DL-lactide) {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, arranged in a way that they also resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 0 7 2003 Ms. Angela J. Silvestri Manager, Regulatory Affairs Sythes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301 Re: K022844 Trade/Device Name: Resorbable Contourable Mesh Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 11, 2002 Received: December 12, 2002 Dear Ms. Silvestri: 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. {2}------------------------------------------------ Page 2 - Ms. Silvestri 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html Sincerely yours Timothy W. Ulatowski Timo Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/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 small "R" in a circle is located to the right of the word, indicating a registered trademark. ## 2.0 Indications for Use Statement Page 1 of 1 | 510(k) Number (if known): | K022844 | |---------------------------|-----------------------------| | Device Name: | Resorbable Contourable Mesh | Indications: Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets, Screws, and Tacks may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. ## Contraindications: These devices are not intended for use in full load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. Synthes Resorbable Fixation System devices are not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. ## (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 CFR 801.109) OR Over-The-Counter Use Susan Puonne (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division Control, Dental Devices KCD 2544 510(k) Number: _