← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K983006 # OSTEO 5.0MM CANNULATED SCREW SYSTEM (K983006) _Stryker Osteonics · HWC · Nov 23, 1998 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K983006 ## Device Facts - **Applicant:** Stryker Osteonics - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Nov 23, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following: - Fixation of intermediate-sized fragments in fractures such as: - proximal and distal humerus fractures - fractures of the olecranon process - femoral fractures - tibial plateau and metaphyseal fractures of the proximal and distal tibia - medial and lateral malleolar and pilon fractures - os calcis, talar, and patellar fractures - . Ligament fixation of the proximal humerus - . Fractures of the pelvis and acetabulum - . Arthrodesis of the tarsals ## Device Story System consists of 5.0mm diameter self-tapping cannulated screws and optional washers; used for bone fracture fixation and ligament fixation. Screws feature 3.2mm shaft, 6.0mm head, and 2.0mm cannulation. Operated by surgeons in clinical settings for orthopedic procedures. Provides mechanical stabilization of bone fragments or ligaments. Anodized Type II coating applied to surfaces. Provided sterile or non-sterile. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Metallic bone fixation fastener; 5.0mm thread diameter; 3.2mm shaft; 6.0mm head; 2.0mm cannulation. Materials: Titanium (implied by predicate comparison). Surface treatment: Type II anodized coating. Sterilization: Provided sterile or non-sterile. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Synthes Titanium 4.5mm Cannulated Screw - ACE Medical Titanium Cannulated Screw and Reconstruction Plate System (4.5mm & 5.0mm cannulated screws) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ NOV 2 3 1998 # 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo 5.0mm Cannulated Screw System K983006 # Submission Information | Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677
201-825-4900 | |-----------------------------------------------------------|----------------------------------------------------------------------------------| | Contact Person: | Kate Sutton
Regulatory Affairs Specialist | | Date Summary Prepared: | August 26, 1998 | | Device Identification | | | Proprietary Name: | Osteo 5.0mm Cannulated
Screw System | | Common Name: | Cannulated Screw | | Classification Name and Reference: | Smooth or Threaded Metallic Bone Fixation
Fastener
21 CFR §888.3040 | ### Predicate Device Identification The subject components of the Osteo 5.0mm Cannulated Screw System are substantially equivalent to the components of the Synthes Titanium 4.5mm Cannulated Screw and the 4.5mm & 5.0mm cannulated screws in the ACE Medical Titanium Cannulated Screw and Reconstruction Plate System. ### Device Description The Osteo 5.0mm Cannulated Screw System consists of 5.0mm thread diameter self-tapping cannulated screws of varying lengths and one washer, the use of which is optional. The 5.0mm screw has a thread diameter of 5.0mm, a shaft diameter of 3.2mm, a head diameter of 6.0mm, and a cannulation diameter of 2.0mm. The washer for the 5.0 screws has an outer diameter of 8.0mm, an inner diameter of 4.5mm, and a thickness of 1.0mm. The surfaces of the screws and washers are anodized with a Type II coating. The screws and washers are provided both sterile and non-sterile. {1}------------------------------------------------ # Intended Use The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following: - Fixation of intermediate-sized fragments in fractures such as: . - proximal and distal humerus fractures - fractures of the olecranon process - femoral fractures - tibial plateau and metaphyseal fractures of the proximal and distal tibia - medial and lateral malleolar and pilon fractures - os calcis, talar, and patellar fractures - - . Ligament fixation of the proximal humerus - . Fractures of the pelvis and acetabulum - . Arthrodesis of the tarsals ## Statement of Technological Comparison The subject components of the Osteo 5.0mm Cannulated Screw Systems are substantially equivalent in design and intended use to the predicate devices offered by Synthes and ACE Medical. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. The text is in all capital letters and is evenly spaced around the circle. NOV 23 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677 K983006 Re: Osteonics 5.0mm Cannulated Screw System Trade Name: Requlatory Class: II Product Code: HWC Dated: August 26, 1998 August 28, 1998 Received: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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. Elizabeth A. Staub 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 requlation (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 one Begandling Storen" (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 (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): K96 3006 ### Device Name: Osteo 5.0mm Cannulated Screw Systems ### Indications For Use: The Osteo 5.0mm Cannulated Screw Systems are indicated for ligament fixation and long and small bone fracture fixation, which may include the following: ### For @5.0mm Cannulated Screws: - . Fixation of intermediate-sized fragments in fractures such as: - proximal and distal humerus fractures - - fractures of the olecranon process - - femoral fractures - - tibial plateau and metaphyseal fractures of the proximal and distal tibia a - medial and lateral malleolar and pilon fractures - - os calcis, talar, and patellar fractures - - Ligament fixation of the proximal humerus . - . Fractures of the pelvis and acetabulum - . Arthrodesis of the tarsals . — — — — — — # (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 | |--------------------------------------------|---------|----| | (Per 21 CFR 801.109) | | | | signature | | | | (Division Sign-Off) | | | | Division of General Restorative Devices | | | | 510(k) Number | K983006 | | Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K983006](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K983006) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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