OSTEO 4.0MM CANNULATED SCREW SYSTEM

{0}------------------------------------------------ MAY 1 1 1998 # 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo 4.0mm Cannulated Screw System Submission Information Name and Address of the Sponsor of the 510(k) Submission: Contact Person: Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 Kate Sutton Regulatory Affairs Specialist Date Summary Prepared: Device Identification Proprietary Name: Common Name: Classification Name and Reference: Osteo 4.0mm Cannulated Screw System Cannulated Screws March 27, 1998 Smooth or Threaded Metallic Bone Fixation Fastener 21 CFR 888.3040 ### Predicate Device Identification The subject components of the Osteo 4.0mm Cannulated Screw System are substantially equivalent to the components of the Synthes 4.0mm Cannulated Screws in the Synthes 4.0mm Screw Set, the ACE Medical 4.0mm Cannulated Screws in the ACE Titanium 3.5/4.0mm Small Fragment System, and the Richards 4.0mm Cannulated Screw. ### Device Description The Osteo 4.0mm Cannulated Screw System consists of one self-tapping cannulated screw of various lengths, and one washer. All components of the system are provided both sterile and non-sterile. The screw and washer are manufactured from Titanium 6Al-4V ELI alloy. The screw thread diameter is 4.0mm. The washer has an outer diameter of 7.0mm and an inner diameter of 4.0mm. {1}------------------------------------------------ ## Intended Use The Osteo 4.0mm Cannulated Screw System is indicated for the following: - Fractures of the olecranon, distal humerus . - Fractures of the ulna and radius . - . Patellar fractures - Distal tibia and pilon fractures . - Fractures of the tarsals and metatarsals ● - Tarso-metatarsal and metatarso-phalangeal arthrodeses . - Metatarsal and phalangeal osteotomies ● - Osteochrondritis dissecans . - Ligament fixation . - Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring . - Other small fragment, cancellous bone fractures . # Statement of Technological Comparison The subject Osteo 4.0mm Cannulated Screw System components are substantially equivalent in design and intended use to the predicate devices offered by Synthes, ACE Medical, and Richards. {2}------------------------------------------------ Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers of the bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 1 1998 Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey Re : K981259 Osteo 4.0mm Cannulated Screw System Regulatory Class: II Product Code: HWC Dated: April 2, 1998 Received: April 6, 1998 Dear Ms. Staub: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section ---513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly: - The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and - 2. You may not label or in any way promote this device for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this {3}------------------------------------------------ Page 2 - Ms. Elizabeth A. Staub device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note {4}------------------------------------------------ ## Page 3 - Ms. Elizabeth A. Staub the regulation entitled, "Misbranding by reference to enc regaracion" (21 CFR 807.97) . Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the bivibion of (800) 638-2041 or (301) 443-6597 or at at Its Coli Free namber (0:0)/www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### 510(k) Number (if known): K98|259 ### Device Name: Osteo 4.0mm Cannulated Screw System ### Indications For Use: The indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows. The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following: - Fractures of the olecranon, distal humerus - Fractures of the ulna and radius . - Patellar fractures . - Distal tibia and pilon fractures . - Fractures of the tarsals and metatarsals . - Tarso-metatarsal and metatarso-phalangeal arthrodeses . - Metatarsal and phalangeal osteotomies . - Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring - Other small fragment, cancellous bone fractures (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Use (Per 21 CFR 801:109) (Optional Format 1-2-96) toco Deyto Sign-Off Division of General Restorative Devices 510(k) Number .