WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW

K961157 · Whiteside Biomechanics, Inc. · HWC · May 17, 1996 · Orthopedic

Device Facts

• Record ID: K961157
• Device Name: WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
• Applicant: Whiteside Biomechanics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 17, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This bone fixation screw is intended for human implantation into prepared bone during orthopedic surgery when the surgeon determines the need for additional fixation (example: fixation of acetabular cup in total hip replacement, fracture fixation, tibial tray fixation, etc.). There is a broad spectrum of uses for this device and the specific use should be determined by the surgeon using sound medical judgment.

Device Story

Self-tapping cancellous bone screw; 6.5mm outer diameter; 3.5mm hexagonal socket drive; radiused head for ballnoise countersunk holes. Used in orthopedic surgery; surgeon drills pilot hole; measures depth; drives screw using socket-driver. Provides mechanical fixation for bone fragments or implants. Sterile, single-use device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Wrought titanium 6Al-4V (ASTM F136). Dimensions: 6.5mm outer diameter, 15mm-50mm lengths (5mm increments). Drive: 3.5mm hexagonal socket. Sterilization: Sterile, double-pouched; do not resterilize.

Indications for Use

Indicated for human implantation into prepared bone during orthopedic surgery requiring additional fixation, including acetabular cup fixation in total hip replacement, fracture fixation, and tibial tray fixation.

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.

Submission Summary (Full Text)

{0}

K961157

# 510(k) Statement

## Device:

Classification Name: Screw, Fixation, Bone
Classification No.: Class II, 87HWC, 868.3040
Common/Usual Name: Cancellous Bone Screw
Proprietary Name: Whiteside Biomechanics
Cancellous Bone Screw

## Manufacturer Identification:

Whiteside Biomechanics
12634 Olive Blvd.
Creve Coeur, MO 63141

**Establishment Registration Number:** 1932213

## Device Description:

The Whiteside Biomechanics Cancellous Bone Screw is a self-tapping screw. The head of the screw has a standard (3.5mm) hexagonal socket drive and the underside is radiused (0.172") to fit a ballnoise countersunk hole (0.344"). The thread is generally a helical spiral about the screw's longitudinal axis and has a large outer diameter (6.5mm) designed to affix in healthy cancellous bone.

The insertion of the Whiteside Biomechanics Cancellous Bone Screw is similar to most registered bone screws on the market today. After determining the need for additional fixation the surgeon drills a pilot hole, using a depth gauge to determine the proper screw length, and drives the screw into the prepared hole using a socket-driver with a hexagonal head.

## Intended Use:

This bone fixation screw is intended for human implantation into prepared bone during orthopedic surgery when the surgeon determines the need for additional fixation (example: fixation of acetabular cup in total hip replacement, fracture fixation, tibial tray fixation, etc.). There is a broad spectrum of uses for this device and the specific use should be determined by the surgeon using sound medical judgment.

## Additional Information:

This cancellous bone screw is made of wrought titanium 6Al-4V (ASTM F136) and is available in 5mm increments from 15mm to 50mm. These bone screws will be provided sterile and double pouched. Resterilization of screws upon contamination is not recommended. DO NOT RESTERILIZE.

#