Who is the manufacturer of ACUMED SUTURE WASHER?

Acu Med, Inc. filed the 510(k) submission for ACUMED SUTURE WASHER (K965028).

What is the FDA product code for ACUMED SUTURE WASHER?

HTN. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ACUMED SUTURE WASHER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ACUMED SUTURE WASHER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACUMED SUTURE WASHER

K965028 · Acu Med, Inc. · HTN · Mar 17, 1997 · Orthopedic

Device Facts

Record ID	K965028
Device Name	ACUMED SUTURE WASHER
Applicant	Acu Med, Inc.
Product Code	HTN · Orthopedic
Decision Date	Mar 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
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.

Indications for Use

Indicated for soft tissue, small bone, and large bone fixation. Contraindicated for use in the spine.

Regulatory Classification

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

Related Devices

K994202 — ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM · Smith & Nephew, Inc. · Feb 25, 2000
K012572 — SOFT TISSUE SCREW AND WASHER · Biomet, Inc. · Dec 3, 2001
K180118 — Arthrex NanoSuture Anchor · Arthrex, Inc. · Feb 12, 2018
K090075 — PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 · Parcus Medical, LLC · Mar 6, 2009
K110545 — SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) · Smith & Nephew, Inc. · Jun 24, 2011

Submission Summary (Full Text)

{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.