SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

K964416 · Synthes (Usa) · KWQ · Mar 17, 1997 · Orthopedic

Device Facts

• Record ID: K964416
• Device Name: SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 17, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SYNTHES (USA) Universal Spinal Parallel Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-L5).

Device Story

Synthes Universal Spinal Rod and Screw Fixation System includes rods, side-opening screws (6, 7, 8 mm), staples, washers, and parallel connectors. Device attaches to anterolateral vertebral body (T8-L5) to provide spinal fixation. Used by surgeons in clinical settings for deformity correction and stabilization. System components connect via rods to stabilize thoracolumbar spine. Benefits include structural support for spinal alignment and fracture management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparison to predicate device.

Technological Characteristics

Components manufactured from implant-grade stainless steel and titanium alloy (Ti-6Al-4V). System includes rods, side-opening screws (6-8mm), staples, washers, and parallel connectors. Non-sterile; recommended sterilization via moist heat.

Indications for Use

Indicated for patients requiring correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Acromed Kaneda SR (Smooth Rod) Anterior Spinal System

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Information
[510(k) Summary]

SYNTHES (U.S.A.)
1690 Russell Road
Paoli, PA 19301

MAR 17 1997

[phone]
Contact: Angela Silvestri

Device:

SYNTHES (U.S.A.) Universal Spinal Rod, and Screw Fixation System Parallel Connector compared to the Acromed Kaneda SR (Smooth Rod) Anterior Spinal System Transverse Couplers.

The Synthes Universal Spinal Rod and Screw Fixation System consists of rods, and 6, 7, and 8 mm diameter side-opening screws with a collar and nut. The system also includes a staple, a washer and a parallel connector. The Universal Spinal side-opening screws attach to the anterolateral portion of the vertebral body of the thoracolumbar spine (levels T8-L5) and are connected via a rod.

The SYNTHES (USA) Universal Spinal Parallel Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-L5).

The Acromed Kaneda SR (Smooth Rod) Anterior Spinal System has the same intended use and is also indicated for correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of thoracolumbar fractures like the Universal Spinal Parallel Connector.

The Acromed Kaneda SR (Smooth Rod) Anterior Spinal is manufactured from certified Implant Grade stainless steel and a titanium alloy (Ti-6Al-4V). This system is similar in component dimensions and sizes to the SYNTHES (U.S.A.) Universal Spinal Parallel Connector.

The Synthes Universal Spinal Rod and Screw Fixation System Parallel Connector is provided non-sterile; moist heat sterilization is recommended.

Based on the above, the SYNTHES (U.S.A.) Universal Spinal Parallel Connector is substantially equivalent to Acromed Kaneda SR (Smooth Rod) Anterior Spinal System.

87821920191:73L

S3H↓NAS 00:11 (03M)∠6.21-8W