← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K963172 # SYNTHES STERILE 4.5 MM CANNULATED SCREWS (K963172) _Synthes (Usa) · HWC · Nov 8, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963172 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Nov 8, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Synthes 4.5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. ## Device Story Device: 4.5 mm cannulated screws; stainless steel or Ti alloy construction. Input: guide wire for precise placement. Operation: self-drilling/self-tapping flutes; cancellous threads. Output: mechanical fixation of long bone fractures. Usage: clinical setting; orthopedic surgeon. Benefit: precise placement via guide wire; stabilization of bone fragments. ## Clinical Evidence Bench testing only; mechanical testing performed to demonstrate equivalence to predicate. ## Technological Characteristics Materials: stainless steel or Ti alloy. Features: 4.5 mm diameter, cannulated design, self-drilling/self-tapping flutes, cancellous threads. Sterilization: gamma radiation. ## 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 4.0 mm Cancellous 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. -06' 96 (WED) 16:50 SYNTHES M96 3172 TEL: 16102512848 P. 003 NOV - 8 1996 Attachment B: Summary of Safety and Effectiveness Information Synthes (USA) (610) 647 - 9700 1690 Russell Road Contact: Angela J. Silvestri P.O. Box 1766 August 1996 Paoli, PA 19301 Synthes Sterile 4.5 mm Cannulated Screws are compared to Synthes 4.0 mm Cancellous Screws. Synthes 4.5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. Synthes 4.5 mm Cannulated Screws are available in various thread length configurations (partially or fully threaded). The 4.5 mm Cannulated Screw features self-drilling/self-tapping flutes and cancellous threads for use in cancellous bone. The screws are used in conjunction with a guide wire for precise placement in bone. Synthes 4.5 mm Cannulated Screws are manufactured from stainless steel or Ti Alloy. Synthes 4.5 mm Cannulated Screws will be provided sterile, gamma radiation will be used to sterilize the device. Based on mechanical testing, Synthes 4.5 mm Cannulated Screws are at least equivalent to Synthes 4.0 mm Cancellous Screws. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963172](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963172) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com