ORTHOFIX TIBIAL NAILING SYSTEM

K961027 · Orthofix, Inc. · HSB · May 8, 1996 · Orthopedic

Device Facts

• Record ID: K961027
• Device Name: ORTHOFIX TIBIAL NAILING SYSTEM
• Applicant: Orthofix, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: May 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is indicated for fixation of the following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.

Device Story

Orthofix Tibial Nailing System; intramedullary fixation device for tibial fractures. System includes solid and cannulated nails (8-14 mm diameter; 240-440 mm length), locking screws, end caps, and surgical instrumentation. Used by orthopedic surgeons in clinical/OR settings for fracture stabilization. Nails implanted into tibial canal to provide mechanical support for bone healing. Device provides structural fixation for acute/pathological fractures, non-unions, and osteotomies. Benefits include stabilization of bone segments to facilitate union.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Surgical grade stainless steel (AISI 316L). Design: Intramedullary nails with proximal bend, proximal/intermediate/distal locking holes. Dimensions: 8-14 mm diameter, 240-440 mm length. Configurations: Solid and cannulated. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring fixation of acute traumatic fractures, pathological fractures, delayed or non-unions, stabilization after corrective osteotomy, or bone transport, specifically for areas distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Orthofix Unreamed Tibial Nail System (K912420)
• Synthes Universal & UTN Systems (K914453)
• Richards Russell Taylor System

Submission Summary (Full Text)

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k961027

510(k) SUMMARY
Orthofix® Tibial Nailing System
March 13, 1996
MAY - 8 1996

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarke notification was in accordance with 21 CFR 807.87 and the SMDA.

1. Submitter of 510(k)

Robert L. Sheridan (Consultant)
Vice President, Device Evaluation
C.L. McIntosh & Associates, Inc.
12300 Twinbrook Parkway, Suite 625
Rockville, MD 20852

Telephone: [phone]
Facsimile: [phone]

2. Name of Device:

A. Trade/Proprietary Name:
Orthofix® Tibial Nailing System

B. Common/Usual Name:
Tibial Nailing System

C. Classification Name:
"Intramedullary Fixation Rod" (21 CFR 888.3020).

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3. Sponsor/Manufacturer:

ORTHOFIX Srl.
Via delle Nazioni 9
37012 Bussolengo (VR), Italy

Attention: Rolando Stanghellini, Director of Quality Assurance
Telephone: [phone]
Facsimile: 011-39-45-6767135

4. Reason for Submitting the 510(k)

This 510(k) is submitted to notify FDA of Orthofix’s intention to commercially distribute its previously cleared Unreamed Tibial Nail System with additional tibial nails and instrumentation. The current system will include solid and cannulated nails for reamed and unreamed use.

5. Device Description

The Orthofix Tibial Nailing System includes a series of tibial nails of varying diameters and lengths, locking screws and end caps, as well as the instruments and accessories used in their implantation and removal.

The system will include tibial nails which range from 8 to 14 mm in diameter and from 240 to 440 mm in length. These nails are manufactured from surgical grade stainless steel (AISI 316L) and include both solid and cannulated constructions. Nails are included for reamed and unreamed use. The nails have a proximal bend and may contain proximal, intermediate and distal locking holes.

6. Intended Use

The system is indicated for fixation of the following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.

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7. Substantial Equivalence

The Orthofix Unreamed Tibial Nail System, K912420, originally received 510(k) clearance on September 23, 1991. Orthofix will now offer a greater selection of tibial nails. The nails will include solid and cannulated constructions for reamed and unreamed use. Additional instruments (e.g., reamers) have also been added to the system to meet the surgical requirements of the added tibial nails.

The information provided in this submission demonstrates that the Orthofix Tibial Nailing System with the additions cited remains substantially equivalent to itself and other legally marketed predicate devices, such as the Synthes' Universal & UTN Systems (K914453) and Richards' Russell Taylor System.

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