SILKON STAINLESS STEEL CABLE SYSTEM

K962132 · Osteonics Corp. · JDQ · Aug 8, 1996 · Orthopedic

Device Facts

• Record ID: K962132
• Device Name: SILKON STAINLESS STEEL CABLE SYSTEM
• Applicant: Osteonics Corp.
• Product Code: JDQ · Orthopedic
• Decision Date: Aug 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Silkon™ Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, kyphosis, and lordosis deformities. The Osteonics® Silkon™ Stainless Steel Cable System is also indicated for trochanteric reattachment, sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle.

Device Story

System consists of multi-strand stainless steel cables (single or Y-design) with monofilament leaders and stainless steel crimps. Used for bone fixation/cerclage in orthopedic and spinal procedures. Operated by surgeons in clinical/OR settings to secure bone segments. Provides mechanical stabilization of fractures or deformities. Sterile offering added to existing product line.

Clinical Evidence

No clinical data; bench testing not required as device is identical to predicate.

Technological Characteristics

Multi-strand stainless steel cable; monofilament wire leader; stainless steel crimp. Mechanical fixation device. Sterile.

Indications for Use

Indicated for patients requiring bone fixation for cervical, thoracic, and lumbar spinal trauma; correction of scoliosis, kyphosis, and lordosis; trochanteric reattachment; sternotomy; and trauma to the shoulder, elbow, hip, knee, and ankle.

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

• AME® Silkon™ Cable System (K932687)

Submission Summary (Full Text)

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K962132
AUG - 8 1996

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness for the Osteonics® Silkon™ Stainless Steel Cable System

### Submission Information

**Name and Address of the Sponsor of the 510(k) Submission:**
Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677

**Contact Person:**
Chuck Ryan
Regulatory Affairs Team Leader

**Date of Summary Preparation:**
August 2, 1996

### Device Identification

**Proprietary Name:**
Osteonics® Silkon™ Stainless Steel Cable System, which includes the following components:
- Osteonics® Silkon™ Stainless Steel Single Cable
- Osteonics® Silkon™ Stainless Steel Y Cable
- Osteonics® Silkon™ Stainless Steel Crimp

**Common Name:**
Cerclage Fixation Components

**Classification Name/Reference:**
Bone Fixation Cerclage
21 CFR §888.3010

### Overview:

The purpose of this 510(k) premarket notification is to address the addition of a sterile offering of this system.

### Predicate Device Identification:

The components of the Osteonics® Silkon™ Stainless Steel Cable System are substantially

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Osteonics® Silkon™ Stainless Steel Cable System
510(k) Summary

equivalent to those of the AME® Silkon™ Cable System, which was determined substantially equivalent by the U.S. Food and Drug Administration (FDA) via 510(k) Premarket Notification #K932687.

## Description of Devices:

The Osteonics® Silkon™ Stainless Steel Cable System consists of two designs: a single, multi-strand, stainless steel cable with an individual monofilament wire leader and a stainless steel crimp; or one multi-strand, stainless steel, double cable with a monofilament Y-Leader and two stainless steel crimps.

## Intended Use:

The Osteonics® Silkon™ Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, kyphosis, and lordosis deformities. The Osteonics® Silkon™ Stainless Steel Cable System is also indicated for trochanteric reattachment, sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle.

## Statement of Technological Comparison:

The designs and stainless steel material characterizing the components of the Osteonics® Silkon™ Stainless Steel Cable System are identical to those of the predicate AME® Silkon™ Cable System.

## Performance Data:

As the components of the Osteonics® Silkon™ Stainless Steel Cable System remain identical to those of the predicate AME® Silkon™ Cable System, which has been determined substantially equivalent via 510(k) Premarket Notification #K932687, no additional performance data is deemed necessary.

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