← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K963192 # SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) _Synthes (Usa) · HWC · Nov 8, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963192 ## 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 3.5 mm and 4.0 mm Cannulated Screws are intended for fracture fixation of small bones and small bone fragments. ## Device Story Cannulated screws (3.5 mm and 4.0 mm) designed for small bone fracture fixation; used with guide wire for precise placement. 3.5 mm version features reverse cutting flutes and cortical threads; 4.0 mm version features self-drilling/self-tapping tips, reverse cutting flutes, and cancellous threads. Provided sterile via gamma radiation. Used by surgeons in clinical settings to stabilize bone fragments, facilitating healing. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: Not specified. Dimensions: 3.5 mm and 4.0 mm diameters. Features: Cannulated design for guide wire, reverse cutting flutes, cortical/cancellous threads, self-drilling/self-tapping tips (4.0 mm). 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 2.7 mm Cortex Screws ([K963192](/device/K963192.md)) ## Reference Devices - Richards 4.0 mm Cannulated Screw - Alphatec Titanium Cannulated Mini Lag Screw System ## 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} Attachment A: Summary of Safety and Effectiveness Information NOV - 8 1996 Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301 (610) 647 - 9700 Contact: Angela J. Silvestri August 1996 K963192 Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws are compared to Synthes 2.7 mm Cortex Screws. Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fracture fixation of small bones and small bone fragments. Synthes 3.5 mm and 4.0 mm Cannulated Screws are available in multiple thread length configurations (partially or fully threaded). The 3.5 mm Cannulated Screws feature reverse cutting flutes and cortical threads. The 4.0 mm Cannulated Screws feature self-drilling/self-tapping tips, reverse cutting flutes and cancellous threads. Both screws are used in conjunction with a guide wire for precise placement in bone. Additionally, the Richards 4.0 mm Cannulated Screw and the Alphatec Titanium Cannulated Mini Lag Screw System are commercially available devices that are also similar to Synthes 3.5 and 4.0 mm Cannulated Screws. Synthes 3.5 mm and 4.0 mm Cannulated Screws will be provided sterile; gamma radiation will be used to sterilize the device. Based on mechanical testing, Synthes 3.5 mm and 4.0 mm Cannulated Screws are at least equivalent to Synthes 2.7 mm Cortex Screws. 88821920191:73L S3H⊥NAS 12:∠I (3N⊥)96.90- 'AON --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963192](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K963192) **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