← Product Code [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN) · K965028 # ACUMED SUTURE WASHER (K965028) _Acu Med, Inc. · HTN · Mar 17, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K965028 ## Device Facts - **Applicant:** Acu Med, Inc. - **Product Code:** [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN.md) - **Decision Date:** Mar 17, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine. ## Device Story Acumed Suture Washer; used for soft tissue and bone fixation; functions with 3.5mm or 4.0mm titanium bone screws and sutures. Device features 2.6mm post height and 8.0mm outer diameter. Used by surgeons in clinical settings for orthopedic fixation procedures. Provides mechanical interface for suture attachment to bone/tissue. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Titanium alloy per ASTM F 136; 2.6mm post height; 8.0mm outer diameter; gamma radiation sterilized (min 2.5 Mrads) per AAMI Method 1; SAL 10⁻⁶. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Linvatec 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} ACUMED™ K965028 Quality Orthopaedic Instruments and Implants # Enclosure D - 510(k) Summary MAR 17 1997 This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93. The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine. This washer has a post height of 2.6mm and an outer diameter of 8.0mm. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided sterile. Sterility is achieved by a minimum of 2.5 Mrads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility assurance level is 10⁻⁶. We make no claims as to the pyrogenicity of this product. Packaging and labeling information have already been provided. The Acumed Suture Washer is similar to the Linvatec Spiked Washer in material, design, and intended usage and is expected to perform as well as similar devices. 10950 SW 5th St., Suite 170 ◆ Beaverton, OR 97005 ◆ (503) 627-9957 ◆ Fax: (503) 520-9618 ◆ Form # FWSH-02 12/12/96 Page 9 of 11 © 1996, Acumed, Inc. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K965028](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K965028) **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