HEIDELBERG EXTERNAL FIXATOR

K970751 · Smith & Nephew, Inc., Orthopaedic Div. · JDW · Apr 16, 1997 · Orthopedic

Device Facts

• Record ID: K970751
• Device Name: HEIDELBERG EXTERNAL FIXATOR
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: JDW · Orthopedic
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the Heidelberg Fixator include: fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Device Story

Modular unilateral, extensible external fixator; used for bone stabilization and deformity correction. Components constructed from aluminum, stainless steel, cobalt alloy, brass, and nylon. Device applied by orthopedic surgeons in clinical/surgical settings to stabilize bone segments. Provides mechanical support for fracture healing, limb lengthening, and arthrodesis. Operates via external fixation principles consistent with predicate unilateral fixator systems.

Clinical Evidence

No clinical data provided; safety and effectiveness based on historical market use of similar external fixator devices.

Technological Characteristics

Modular unilateral, extensible external fixator. Materials: aluminum, stainless steel, cobalt alloy, brass, nylon. Mechanical fixation principle. No energy source or software.

Indications for Use

Indicated for patients requiring fracture fixation (open/closed), treatment of pseudoarthrosis or nonunion of long bones, limb lengthening, correction of bony or soft tissue deformities, correction of segmental bony or soft tissue defects, and joint arthrodesis.

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

• Hex-Fix Field Fixator (K953397)
• Orthofix External Fixator (K802814)
• Ilizarov External Fixator System (K870961)

Submission Summary (Full Text)

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K970751

# Summary of Safety and Effectiveness
## Heidelberg External Fixator

APR 16 1997

## Substantial Equivalence Information

The Heidelberg External Fixator is substantially equivalent to the following:

1. Hex-Fix Field Fixator--K953397
2. Orthofix External Fixator--K802814
3. Ilizarov External Fixator System--K870961

All of the devices listed above have similar indications for use, similar materials composition, and similar design. The safety and effectiveness of external fixators is based on the long history of use of these devices in the market place.

## Device Description

The Heidelberg External Fixator is a modular unilateral, extensible device used for the indications listed previously. Components are made of aluminum, stainless steel, cobalt alloy, brass, and nylon which are similar to materials used in other unilateral fixators.

## Indications for Use

Indications for the Heidelberg Fixator include: fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

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