← Product Code [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW) · K963973 # DEPUY CANNULATED CROSS PIN SCREW SYSTEM (K963973) _Depuy, Inc. · JDW · Dec 16, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K963973 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW.md) - **Decision Date:** Dec 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction. ## Device Story Cannulated cross pin screws; titanium alloy; headless; proximally threaded; smooth shanks with two tapers; blunt distal tip. Used in ACL reconstruction; provides early fixation of autogenous or allogeneic tendon grafts. Operated by orthopedic surgeons in OR. Cannulated design allows use with guide pins. Available in 45mm-75mm lengths. Benefits include secure graft fixation during ligament reconstruction. ## Clinical Evidence Bench testing only. ## Technological Characteristics Titanium alloy; cannulated; headless; proximally threaded; smooth shanks with dual tapers; blunt distal tip; lengths 45-75mm. ## 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 Titanium Cross Pin Screw System ([K954630](/device/K954630.md)) - DePuy Cross Pin Screw System ([K946228](/device/K946228.md)) - Arthrex SemiFix ACL Reconstruction 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} K963973 # SUMMARY OF SAFETY AND EFFECTIVENESS DEC 16 1996 ## NAME OF FIRM: DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 ## FIRM CONTACT: Arlene Saull, RAC Manager, Medical Device Submissions ## TRADE NAME: DePuy Cannulated Cross Pin Screw System ## COMMON NAME: Threaded fixation pin ## CLASSIFICATION: Smooth or threaded metallic bone fixation fastener (21 CFR Part 888.3040) Class II ## DEVICE PRODUCT CODE: 87 JDW Pin, Threaded ## SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Titanium Cross Pin Screw System DePuy Cross Pin Screw System Arthrex SemiFix ACL Reconstruction System ## DEVICE DESCRIPTION AND INTENDED USE: The DePuy Cannulated Cross Pin Screw System contains cross pin screws manufactured from titanium alloy which are headless, proximally threaded with smooth shanks containing two tapers; the most distal taper being the smaller diameter tapering to a blunt tip. They are cannulated for use with their accompanying guide pins. The cross pin screws will be available in seven lengths ranging from 45mm to 75mm in 5mm increments. The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction. ## BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Cannulated Cross Pin Screw System is substantially equivalent to the DePuy Titanium Cross Pin Screw System (K954630), the DePuy Cross Pin System (K946228), and the Arthrex SemiFix ACL Reconstruction System. The substantial equivalency is based on similar material, intended uses and design. 1 OR --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K963973](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K963973) **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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