ALTA CFX IM ROD SYSTEM

K960524 · Howmedica Corp. · HSB · Mar 22, 1996 · Orthopedic

Device Facts

• Record ID: K960524
• Device Name: ALTA CFX IM ROD SYSTEM
• Applicant: Howmedica Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Device Story

Intramedullary fixation rod system; diameters 11mm, 13mm, 15mm; lengths 300mm-480mm. Includes locking screws for reconstructive and interlocking applications. Used by orthopedic surgeons in clinical/OR settings for fracture stabilization. Provides mechanical support to bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intramedullary rod system; diameters 11-15mm; lengths 300-480mm; includes locking screws. Mechanical fixation device.

Indications for Use

Indicated for fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures; temporary stabilization of femoral shaft fractures from femoral neck to supracondylar regions.

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

• Howmedica Alta® CFx IM Rod System (K926232)
• Howmedica Alta® Femoral IM Rod System (K850441)
• Howmedica Grosse & Kempf Locking Nail (K813371A)
• Ace Medical AIM Femoral System
• Zimmer ZMS Recon Nail System

Submission Summary (Full Text)

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510(k) Summary

R960s24

Proprietary Name: Alta® CFx IM Rod System

Common Name: Intramedullary Fixation Rod

Classification Name and Reference: 21 CFR 888.3020
Intramedullary Fixation Rod

MAR 22

Proposed Regulatory Class: Class II
Device Product Code: OR(87) HSB

For Information Contact: Frank Maas
Manager, Regulatory Affairs
Howmedica, Inc.
359 Veterans Boulevard
Rutherford, N.J. 07070
Telephone: [phone]
Fax: [phone]
Date Summary Prepared: 1-31-95

The Alta® CFx IM Rod System is a series of intramedullary rods in diameters of 11mm, 13mm, and 15mm with lengths of 300mm to 480mm.

These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Locking screws are available for both reconstructive and interlocking indications.

The substantial equivalence of these rods and screws is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® CFx IM Rod System and Alta® Femoral IM Rod System (K926232 & K850441), Howmedica's Grosse & Kempf Locking Nail (K813371A), Ace Medical's AIM Femoral System, and Zimmer's ZMS Recon Nail System.