EXTREMITY BONE SCREW

K963118 · Acu Med, Inc. · HWC · Oct 10, 1996 · Orthopedic

Device Facts

• Record ID: K963118
• Device Name: EXTREMITY BONE SCREW
• Applicant: Acu Med, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 10, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The 2.7mm Extremity Bone Screw is intended for fracture and osteotomy fixation of the upper and lower extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc.

Device Story

2.7mm titanium alloy bone screw; used for fracture and osteotomy fixation in upper and lower extremities; driven by 2.5mm hex head; provided non-sterile; requires steam sterilization by user; intended for surgical use by physicians; provides mechanical fixation of bone fragments.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Titanium alloy per ASTM F 136. Dimensions: 2.7mm diameter; lengths 12-24mm. Drive: 2.5mm hex head per ASTM F 543. Sterilization: Steam sterilization (SAL 10⁻⁶).

Indications for Use

Indicated for fracture and osteotomy fixation of upper and lower extremities. Contraindicated for use in the spine and use with bone plates or washers.

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

• Synthes' 3mm Cannulated Screw System

Submission Summary (Full Text)

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OCT-08-1996 12:34 FROM ACUMED INC TO 13018274349 P.04
ACUMED™ K963118
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary OCT 10 1996

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 2.7mm Extremity Bone Screw is intended for fracture and osteotomy fixation of the upper and lower extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc. This screw is available in lengths of 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, and 24mm. The screw is driven by a conventional 2.5mm hex head. Hex dimensions are in accordance with ASTM F 543. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided non-sterile. On file at Acumed is test data which shows that the screw can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 10⁻⁶. As the screw is provided non-sterile, packaging information is not provided.

The 2.7mm Extremity Bone Screw is similar to Synthes' 3mm Cannulated Screw System in design, function, indications, and surgical technique and is expected to perform as well as similar devices.

10950 SW 5th St., Suite 170 • Beaverton, OR 97005 • [phone] • Fax: [phone] • Form # FFAS-11-01 10/08/96 Page 8 of 10 © 1996, Acumed, Inc.