DALL-MILES HOMOGENOUS VITALLIUM CABLE

K961283 · Howmedica Corp. · JDQ · May 22, 1996 · Orthopedic

Device Facts

• Record ID: K961283
• Device Name: DALL-MILES HOMOGENOUS VITALLIUM CABLE
• Applicant: Howmedica Corp.
• Product Code: JDQ · Orthopedic
• Decision Date: May 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The original Homogeneous cable is intended to be used for spinal wiring, trochanter reattachment, sternotomy applications, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Indications for the stabilization of bone graft material and for fracture fixation when used in conjunction with bone plates and screws have been added.

Device Story

Dall-Miles Homogeneous Vitallium Cable; bone fixation cerclage device. Used for orthopedic stabilization; spinal wiring; trochanter reattachment; sternotomy; trauma surgery; bone graft stabilization; fracture fixation with plates/screws. Operates as mechanical fixation implant. No changes in design, materials, or manufacturing from predicate (K945294).

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence based on design identity to predicate and equivalence of intended use to existing marketed devices.

Technological Characteristics

Material: Vitallium. Form factor: Cable. Function: Bone fixation cerclage. No changes in design, materials, or operational principles from predicate.

Indications for Use

Indicated for spinal wiring, trochanter reattachment, sternotomy, trauma surgery of shoulder, elbow, knee, hip, or ankle, stabilization of bone graft material, and fracture fixation in conjunction with bone plates and screws.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Dall-Miles Homogeneous Cable (K945294)
• Dall-Miles Suture/Beaded Cable (K953818)
• Ries Cable System (K875156)
• Control Cable System (K934557)

Submission Summary (Full Text)

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MAY 22 1996
K961283

510(k) Summary

Proprietary Name: Dall-Miles Homogeneous Vitallium® Cable

Common Name: Bone Fixation Cerclage

Classification Name and Reference: Bone Fixation Cerclage
21 CFR 888.3010

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

For information contact:
Frank Maas
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: [phone]
Fax: [phone]
Date Summary Prepared: 4-2-96

This submission describes a modification in intended use of the previously released Dall-Miles Homogeneous Cable (K945294). The original Homogeneous cable is intended to be used for spinal wiring, trochanter reattachment, sternotomy applications, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Indications for the stabilization of bone graft material and for fracture fixation when used in conjunction with bone plates and screws have been added.

There have been no changes in the design, materials, manufacturing, or operational principles of the Dall-Miles Cable.

Substantial equivalence of the additional indications is based on equivalence in intended use to Howmedica's Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557). Each of the named devices are currently marketed for stabilization of bone graft and fracture fixation.