SYNTHES WIRE MOUNT

K953777 · Synthes (Usa) · JDQ · Mar 8, 1996 · Orthopedic

Device Facts

• Record ID: K953777
• Device Name: SYNTHES WIRE MOUNT
• Applicant: Synthes (Usa)
• Product Code: JDQ · Orthopedic
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants.

Device Story

Synthes Wire Mount; T-post design with perpendicular hole and triangular ridge; used with cerclage wire to augment fracture stabilization; inserted through dynamic compression screw hole from bone side of plate; provides anchor point for cerclage wire passed around bone; compatible with various Synthes plates (DHS, DCS, Condylar Buttress, Cobra Head, Hook, 4.5mm DCP, Angle Blade Plates); used in clinical setting by surgeons; facilitates fixation when screws contraindicated due to intramedullary implants.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: 316L stainless steel. Form factor: T-post with hole and triangular ridge. Compatibility: 4.5 mm dynamic compression screw holes. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring fracture stabilization with plates where screw placement is contraindicated, such as in the presence of intramedullary implants.

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

• Synthes Cerclage Wire

Submission Summary (Full Text)

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K953777

# Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]

SYNTHES (USA)
1690 Russell Road
Paoli, PA 19301

[phone]
Contact:
Angela Silvestri
August 11, 1995

Device: Synthes Wire Mount is compared to Synthes Cerclage Wire.

Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the Wire Mount hole above the outer surface of the plate, and then twisted with the opposite wire end.

The device is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. Among the plates the Wire Mount (and cerclage wire) can be used with include, but are not limited, to Dynamic Hip Screw (DHS), Dynamic Condylar Screw (DCS), Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad Dynamic Compression (DCP), 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates) and 130° Angle Blade Plates (including small stature plates). The Wire Mount is manufactured from 316L stainless steel.

Synthes Cerclage Wire is a straight wire that is also intended to augment fracture stabilization with plates when use of screws is contraindicated, e.g., in the presence of intramedullary implants. Among the plates the Cerclage Wire can be used with include, but are not limited to, DHS, DCS, Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad DCP, 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates), and 130° Angle Blade Plates (including small stature plates). It is also manufactured from 316L stainless steel.

Synthes Wire Mount (with cerclage wire) is at least equivalent to Synthes Cerclage Wire, based on the results of the testing of both devices.

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