← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K961649 # ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER (K961649) _Smith & Nephew Endoscopy, Inc. · HWC · Jul 16, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K961649 ## Device Facts - **Applicant:** Smith & Nephew Endoscopy, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jul 16, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures. ## Device Story Device consists of two-part tibial anchor screw and spiked washer; used for soft tissue-to-bone fixation in orthopedic procedures. Outer screw (9mm diameter, 20-30mm length) features cancellous threads for bone contact; inner screw (7mm diameter, 20-25mm length) secures spiked washer (14-20mm diameter) to outer screw. Spikes at washer periphery provide tissue grip. Device implanted by orthopedic surgeons in clinical/OR settings to secure tendons/ligaments. Provides mechanical fixation to facilitate healing. Materials include titanium and reinforced polyacetal polymer. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: Titanium and reinforced polyacetal polymer. Design: Two-part screw system (outer 9mm, inner 7mm) with spiked washer (14-20mm). Mechanical fixation principle. Sterile, single-use. ## 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 - Concept® Soft Tissue Anchoring Implants ([K871037](/device/K871037.md)) - Synthes® Spiked Washer ## 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} JUL 16 1996 K 96/649 # 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is : This summary was prepared on April 26, 1996 ## A. Submitter Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, MA 02048 ## B. Company Contact Tedd Gosian Clinical Regulatory Manager ## C. Device Name Trade Name: Acufex® Tibial Anchor Screw & Spiked Washer Common Name: Fixation Screw & Washer Classification Name: Single/Multiple component metallic bone fixation appliances and accessories ## D. Predicate/Legally Marketed Devices Concept® Soft Tissue Anchoring Implants (K871037) Synthes® Spiked Washer ## E. Device Description Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone fixation. The Tibial Anchor Screw is a two part screw. The outer larger part has cancellous threads, which come in direct contact with bone, and is 9 mm in diameter with a length of 20 - 30 mm. The inner part, 7 mm diameter and 20 - 25 mm length, is used to attach the Spiked Washer directly to the outer part. The spiked washer is 14 - 20 mm in diameter with spikes set at the periphery. ## F. Intended Use The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures. {1} 104 # G. Substantial Equivalence The AcufeX® Tibial Anchor Screw & Spiked Washer is intended for use for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures. The AcufeX® Tibial Anchor Screw & Spiked Washer is similar in design, function, materials and intended use to other devices currently marketed and in commercial distribution, namely Concept® Soft Tissue Anchoring Implants (K871037) and Synthes® Spiked Washer. Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations. A summary comparison of the characteristics of the AcufeX® Tibial Anchor Screw & Spiked Washer and the substantially equivalent device is presented in the table below. | | Current Product | Substantially Equivalent Product | | | --- | --- | --- | --- | | Attribute I | AcufeX® Tibial Anchor Screw & Spiked Washer | Concept® Soft Tissue Anchoring Implants | Synthes® Spiked Washer | | Indication | Soft Tissue Fixation | Soft Tissue Fixation | Ligament Fixation | | Length | Outer: 20 - 30 mm Inner: 18 - 25 | Screw: 25 - 55 mm | | | Diameter | Outer: 9 mm. Inner: 7 mm Washer: 14 - 20 mm O.D. | Screw: 6.5 mm - Washer: 14 to 20 mm O.D. | Washer: 13.5 mm O.D. | | Materials | Screw: Titanium Washer: Titanium Reinforced Polyacetal Polymer | Screw: Titanium Washer: Titanium | Washer: Stainless Steel reinforced polyacetal | | Labeling | Sterile, Single Use Only | Sterile, Single Use Only | Sterile, Single Use | Applicant _Vicki R. Brown_ Date _4/26/96_ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K961649](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K961649) **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