ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER

K961649 · Smith & Nephew Endoscopy, Inc. · HWC · Jul 16, 1996 · Orthopedic

Device Facts

• Record ID: K961649
• Device Name: ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 16, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• 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.

Indications for Use

Indicated for fixation of soft tissue, including tendons and ligaments, to bone during orthopedic surgical procedures.

Regulatory Classification

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)
• Synthes® Spiked Washer

Submission Summary (Full Text)

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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.

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# 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_