MONOTUBE TUBE TO RING CLAMP

K961618 · Howmedica Corp. · JEC · May 28, 1996 · Orthopedic

Device Facts

• Record ID: K961618
• Device Name: MONOTUBE TUBE TO RING CLAMP
• Applicant: Howmedica Corp.
• Product Code: JEC · Orthopedic
• Decision Date: May 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Device Story

External fixation clamp; connects Monticelli/Spinelli circular frame rings to Monotube external fixation system tubes. Enables angulation between circular frame and tube components. Used in orthopedic surgery for fracture stabilization. Physician-operated in clinical/OR settings. Provides hybrid construct combining pin fixation with ring/wire fixation.

Clinical Evidence

Bench testing only. Performance comparison of Monotube Hybrid Frame versus Monticelli/Spinelli Hybrid Frame using Hoffmann External Fixation System components.

Technological Characteristics

Materials: Stainless steel and aluminum. Function: Mechanical fixation clamp for external frame systems. Design: Articulating coupling for angulation between circular rings and fixation tubes.

Indications for Use

Indicated for patients with open and/or unstable fractures where soft tissue injury precludes alternative treatments like IM rodding or casting.

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

• Howmedica Monticelli/Spinelli Sliding Clamp (with Articulating Coupling)
• Synthes Ring-to-Rod Clamp
• Zimmer Torus Ring-to-Rod Clamp

Reference Devices

• Monotube External Fixation System
• Monticelli/Spinelli Circular External Fixation System
• Hoffmann External Fixation System

Submission Summary (Full Text)

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MAY 28 1996 K961618

510(k) Summary

Prepared: April 19, 1996

Trade Name: Monotube® Tube to Ring Clamp
Common Name: External Fixation Clamp
Classification Name: SMOOTH OR THREADED METALLIC BONE
FIXATION FASTENER 888.3040

This submission describes an external fixation clamp to used to provide a hybrid construct combining the pin fixation of the Monotube® External Fixation System with the Ring and wire fixation of the Monticelli/Spinelli Circular External Fixation System. This device is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

The Monotube® Tube to Ring Clamp is designed to connect the Ring of a Monticelli/Spinelli Circular Frame to a Monotube® Tube. The Clamp provides for angulation between the circular frame and the tube of the external frame system. The Clamp is manufactured from Stainless Steel and Aluminum.

Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Howmedica Monticelli/Spinelli Sliding Clamp (with Articulating Coupling), the Synthes Ring-to-Rod Clamp and the Zimmer Torus Ring-to-Rod Clamp.

Testing of this device is presented within the submission. Testing was preformed to compare the performance of the Monotube® Hybrid Frame versus a Monticelli/Spinelli Hybrid Frame using components of the Hoffmann External Fixation System.

For information contact: John Dichiara
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone]
Fax: [phone]