OSTEO COMPRESSION HIP SCREW SYSTEM

{0}------------------------------------------------ SEP 2 2 1998 982553 Osteo Compression Hip Screw System - Expanded Indication 510(k) Premarket Notification ## 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION HIP SCREW SYSTEM - EXPANDED INDICATION ### Submission Information | Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation<br>59 Route 17<br>Allendale, NJ 07401-1677<br>201-825-4900 | |-----------------------------------------------------------|----------------------------------------------------------------------------------| | Contact Person: | Marybeth Naughton<br>Regulatory Affairs Team Member | | Date Summary Prepared: | July 17, 1998 | Device Identification | Proprietary Name: | Osteo Compression Hip Screw System | |------------------------------------|----------------------------------------------------------------------------------------------------| | Common Name: | Compression Hip Screw Plate and Screw | | Classification Name and Reference: | Single/Multiple Component Metallic Bone<br>Fixation Appliances and Accessories<br>21 CFR §888.3030 | #### Predicate Device Identification The expanded indication of the subject components of the Osteo Compression Hip Screw System, which is the subject of this premarket notification, are substantially equivalent to the indications of the components of the Synthes DHS® Dynamic Hip Screw System. #### Device Description The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K971654, #K971321 and #K920037, and remain unchanged from these previous submissions. {1}------------------------------------------------ #### Intended Use The Osteo Compression Hip Screw System is cleared for use via 510(k)s #K971654, #K971321 and #K920037 for the following indications: Intertrochanteric femoral fractures and intracapsular femoral neck fractures. The expanded indications for the Osteo Compression Hip Screw System include: extracapsular fractures of the proximal femur (basal neck fractures, trochanteric fractures, and subtrochanteric fractures). ## Statement of Technological Comparison The subject Osteo Compression Hip Screw System components are substantially equivalent in intended use to the predicate devices offered by Synthes in their DHS® Dynamic Hip Screw System. > (Divir ' Div ... . . . . 510(k) Number_ {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized human head in profile, with three wavy lines representing the hair and face. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 2 1998 Ms. Marybeth Naughton Regulatory Affairs Team Member Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677 Re : K982553 Trade Name: Osteo Compression Hip Screw System Regulatory Class: II Product Code: HRS, HWC Dated: July 21, 1998 Received: July 22, 1998 Dear Ms. Naughton: 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). F 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 (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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. {3}------------------------------------------------ Page 2 - Ms. Marybeth Naughton This letter will allow you to begin marketing your device as described in your 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 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 the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://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 {4}------------------------------------------------ 510(k) Number (if Known): K971654, K971321, K920037 Device Name: Osteo Compression Hip Screw - Expanded Indication ### Indications For Use: The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. The Osteo I-C Humeral Nail System is intended for single use only. ## Indications: > Cleared via 510(k)s #K971654, #K971321, #K920037 - > Intracapsular fractures of the femoral neck - ♪ Intertrochanteric fractures Expanded Indication (the subject of this premarket notification) - Extracapsular fractures of the proximal femur: - ♪ basal neck fractures - ♪ trochanteric fractures - > subtrochanteric fractures # (PLEASE DO NOT WRITE BFLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(per 21 CFR 801.109( | <div style="text-align:center;">X</div> | |------------------------------------------|-----------------------------------------| | OR | | | Over-The-Counter Use | | | (Optional Format 1-2-96) | | (Division Sign-Off) Division of General Restorative Devices | 510(k) Number | K982553 | |---------------|---------| |---------------|---------|