HOFFMANN II CARBON CONNECTING ROD

K961916 · Howmedica, Inc. · JEC · Aug 1, 1996 · Orthopedic

Device Facts

• Record ID: K961916
• Device Name: HOFFMANN II CARBON CONNECTING ROD
• Applicant: Howmedica, Inc.
• Product Code: JEC · Orthopedic
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.

Device Story

Carbon fiber reinforced epoxy resin connecting rod; component of Hoffmann® II External Fixation System. Functions as structural connecting element for clamps in external fixation frames; stabilizes open/unstable fractures. Used in clinical settings by orthopedic surgeons/physicians. Provides rigid support for pin fixation of fractures; varying diameters/lengths accommodate different anatomic locations. Benefits patient by enabling fracture stabilization in presence of soft tissue injury.

Clinical Evidence

Bench testing only. Static bending strength/stiffness and torsional strength/stiffness compared against Hoffmann® stainless steel and aluminum rods.

Technological Characteristics

Material: Carbon fiber reinforced epoxy resin. Form factor: Connecting rod of varying diameters and lengths. Function: Structural element for external fixation clamps. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients with open and/or unstable fractures where soft tissue injury precludes other fracture treatments; used for stabilization via external 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.

Predicate Devices

• Hoffmann® Stainless Steel Rods
• Hoffmann® II Aluminum Rods
• Synthes Carbon Fiber Rods
• Monotube External Fixation System Carbon Tubes

Submission Summary (Full Text)

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AUG - 1 1996
K96 1916
510(k) Summary

Trade Name: Hoffmann® II Carbon Connecting Rods
Common Name: External Fixation Rod
Classification Name: Smooth or Threaded Metallic Bone Fixation
Fastener 888.3040

This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.

The rod is designed to provide a connecting element for the clamps in an external fixation frame. It is manufactured from a carbon fiber reinforced epoxy resin.

Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Hoffmann® Stainless Steel Rods, The Hoffmann® II Aluminum Rods, the Synthes Carbon Fiber Rods and the Carbon Tubes of The Monotube External Fixation System.

The Hoffmann® II Carbon Connecting Rods, the Synthes Carbon Fiber Rods and the Monotube Carbon Tubes are all manufactured from carbon fiber reinforced epoxy composites. All of these rods are designed to mate with external fixation clamps, intended to be used as connecting elements in pin fixation of fractures and are of a varying diameters and lengths to address different anatomic locations.

Testing of this device is presented in the submission. Testing was performed to determine static bending strength and stiffness, and torsional strength and stiffness. In each test the Hoffmann® II Carbon Rods were compared to the Hoffmann® stainless steel rods and/or Hoffmann® II aluminum rods.

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