← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K961234 # DEPUY ADVANTAGE FIXATION SCREW SYSTEM (K961234) _Depuy, Inc. · HWC · Jun 19, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K961234 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jun 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction. ## Device Story Titanium alloy cancellous bone screw; used for interference fixation of patellar bone-tendon-bone grafts during ACL reconstruction. Available in 7mm and 9mm diameters; cannulated and non-cannulated versions; various lengths. Features internal hex fitting for surgical insertion. Used by orthopedic surgeons in clinical/OR settings to secure grafts to bone, facilitating ligament reconstruction and joint stability. ## Clinical Evidence No clinical data provided; substantial equivalence based on design, material, and intended use comparison to predicate devices. ## Technological Characteristics Material: Ti-6Al-4V alloy. Design: Fully threaded cancellous bone screw; 7mm and 9mm diameters; cannulated/non-cannulated; 29-degree tapered tip; round body thread; internal hex fitting. Finish: Polished satin. ## 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 - DePuy M. Kurosaka™ Interference Screw - DePuy M. Kurosaka™ Fixation Screw - Arthrex Transtibial™ 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} JUN 19 1996 K961234 SUMMARY OF SAFETY AND EFFECTIVENESS EXHIBIT II NAME OF FIRM: DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 FIRM CONTACT: Sally Foust Clinical Research Specialist TRADE NAME: DePuy Advantage™ Fixation Screw System COMMON NAME: Bone Screw CLASSIFICATION: 888.3040 Smooth or threaded metallic bone fixation fastener DEVICE PRODUCT CODE: 87 HWC SUBSTANTIALLY EQUIVALENT DEVICES: DePuy M. Kurosaka™ Interference Screw DePuy M. Kurosaka™ Fixation Screw Arthrex Transtibial™ System DEVICE DESCRIPTION AND INTENDED USE: The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, 30, 35, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery. The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction. BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Advantage Fixation Screw System screws are substantially equivalent to the DePuy M. Kurosaka Interference Screws cleared for fixation of bone-tendon-bone grafts in ACL reconstruction. All of the DePuy Advantage screws and the M. Kurosaka Interference screws are manufactured from Ti-6Al-4V alloy. All are available in 7mm and 9mm diameters in numerous lengths in cannulated and non-cannulated versions. （） --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K961234](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K961234) **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