MONOTUBE CARBON TUBE

K963614 · Howmedica Corp. · JEC · Nov 6, 1996 · Orthopedic

Device Facts

• Record ID: K963614
• Device Name: MONOTUBE CARBON TUBE
• Applicant: Howmedica Corp.
• Product Code: JEC · Orthopedic
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Monotube® Carbon Tubes, previously cleared in a premarket 510(k) submission, are connecting elements for use with the Monotube® Clamps for the construction of external fixation frames. The tubes are available in 15mm, 20mm and 25mm diameters and a variety of lengths to accommodate varying anatomical situations.

Device Story

Monotube® Carbon Tubes serve as structural connecting elements for external fixation frames; used with Monotube® Clamps. Device facilitates orthopedic stabilization by connecting frame components. Available in 15mm, 20mm, 25mm diameters and various lengths to suit anatomical requirements. Operated by orthopedic surgeons in clinical/surgical settings. Submission addresses changes in material and manufacturing method compared to previously cleared versions.

Clinical Evidence

Bench testing only. Comparative static mechanical property testing of existing vs. new tubes; static axial compressive frame testing to evaluate yield strength and stiffness.

Technological Characteristics

External fixation connecting tubes; diameters 15mm, 20mm, 25mm; variable lengths. Metallic construction (implied by classification 888.3040).

Indications for Use

Indicated for use as connecting elements in external fixation frames for orthopedic stabilization.

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

• Monotube® Carbon Tubes (previously cleared)

Submission Summary (Full Text)

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K963614
510(k) Summary
NOV - 6 1996

Trade Name: Monotube® Carbon Tube
Common Name: External Fixation Tube
Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener 888.3040

The Monotube® Carbon Tubes, previously cleared in a premarket 510(k) submission, are connecting elements for use with the Monotube® Clamps for the construction of external fixation frames. The tubes are available in 15mm, 20mm and 25mm diameters and a variety of lengths to accommodate varying anatomical situations. This present submission describes a change in material and manufacturing method to these tubes.

Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the previously cleared Monotube® Carbon Tubes.

Testing of the devices is presented in the submission. Testing was performed to compare the static mechanical properties of the tube and subassemblies using both the existing tubes and the tubes that are the subject of this submission. Static axial compressive frame testing was also performed to determine frame yield strength and stiffness.

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