CERCLAGE WIRE CRIMP BLOCK

K960651 · Acu-Med, Inc. · JDQ · May 3, 1996 · Orthopedic

Device Facts

• Record ID: K960651
• Device Name: CERCLAGE WIRE CRIMP BLOCK
• Applicant: Acu-Med, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: May 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.

Device Story

Acumed Wire Crimp Sleeve; titanium block with two holes; used with cerclage wire for bone fixation. Wire passed around bone, through crimp block, and crimped. Operation identical to Osteo-Clage Cerclage Cable System and similar to Howmedica Dall-Miles Cable System; primary difference is use of wire instead of cable. Used by orthopedic surgeons in clinical settings for bone repair.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium per ASTM F 136; block with two holes; mechanical crimping mechanism; intended for use with titanium or cobalt chromium cerclage wire.

Indications for Use

Indicated for general orthopedic repairs requiring cerclage wire fixation. No specific age or gender restrictions noted.

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

• Acumed Cerclage Wire Crimp (K931246)
• Osteo-Clage Cerclage Cable System
• Howmedica Dall-Miles Cable System

Reference Devices

• Richards Orthopedic Cable System

Submission Summary (Full Text)

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ACUMED™

Quality Orthopaedic Instruments and Implants

Enclosure D - 510(k) Summary

K960651

MAY - 3 1996

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cerclage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable. It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.

The sleeve is manufactured from titanium per ASTM F 136. It is intended for use with titanium or cobalt chromium cerclage wire.

Information regarding implantation, packaging, and labeling have been provided.

This medical device is identical except for material type to the Acumed Cerclage Wire Crimp (K931246). Both the Acumed Cerclage Wire Crimp and the Richards Orthopedic Cable System are manufactured from titanium. In addition, the Acumed Cerclage Wire Crimp may be found substantially equivalent to the Osteo-Clage Cerclage Cable System and the Howmedica Dall-Miles Cable System, is safe and effective, and is expected to perform as well as similar devices.

e well engine
edic problem
is backed by

Randall H.
ident, Acume

10950 SW 5th St., Suite 170 • Beaverton, OR 97005 • [phone] • Fax: [phone] •

Form # FOCL-22 02/09/96 Page 8 of 9 © 1995, Acumed, Inc.