DALL-MILES STAINLESS STEEL BEADED CABLE

K961569 · Howmedica Corp. · JDQ · Jun 24, 1996 · Orthopedic

Device Facts

• Record ID: K961569
• Device Name: DALL-MILES STAINLESS STEEL BEADED CABLE
• Applicant: Howmedica Corp.
• Product Code: JDQ · Orthopedic
• Decision Date: Jun 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material.

Device Story

Stainless steel cable with electron-beam-melted bead on one end; modification of existing cable design. Used with one-sided tensioner in space-constrained surgical sites where two-sided tensioners are unsuitable. Operates as bone fixation cerclage; provides mechanical stabilization for bone segments or grafts. Used by surgeons in OR settings for orthopedic and trauma procedures. Output is physical fixation of bone/graft; assists in fracture reduction and stabilization; facilitates healing by maintaining bone alignment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel cable; electron-beam-melted bead termination. Mechanical fixation device. No software or energy source.

Indications for Use

Indicated for patients requiring spinal wiring, sternotomy, cerclage procedures, trauma surgery of the shoulder, elbow, knee, hip, or ankle, supplementary fixation with bone plates/screws, or stabilization of bone graft material.

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 Trochanter Cable Grip System (K844068)
• Dall-Miles Trochanter Cable Grip System (K900926)
• Dall-Miles Suture/Beaded Cable (K953818)
• Ries Cable System (K875156)
• Control Cable System (K934557)

Submission Summary (Full Text)

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JUN 24 1996
K961569

510(k) Summary

Proprietary Name: Dall-Miles Stainless Steel Beaded 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
[phone] - Phone
[phone] - Fax

Date Summary Prepared: April 17, 1996

The Dall-Miles Stainless Steel Beaded Cable is a modification of the existing stainless steel cable. A bead is formed on one end of the cable by melting it with an electron beam. This modification allows the cable to be used with a one-sided Tensioner in those applications where a conventional two-sided Tensioner will not fit.

The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material.

The substantial equivalence of the Beaded Cable is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557).