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Spine · Thoracolumbar

RAPIDFIX Dual-lead thoracolumbar screws

Name: RAPIDFIX Dual-lead thoracolumbar screws
Brand: Normmed

Pedicle screws with dual-lead thread.

EU MDR

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Overview

RAPIDFIX is a posterior fixation system for the thoracic, lumbar and sacral spine, T4 to S1, with a dual-lead thread. The range covers polyaxial, listhesis, monoaxial and cannulated screws on one instrument set, and the screws also accept the ATLAS derotation sleeves.

Product group: Spine
System: Thoracolumbar
Anatomical region: Thoracolumbar spine
Material: Titanium alloy; rods in titanium alloy or Cr-Co
Device class (EU MDR): IIb
Manufacturer: NORMMED MEDİKAL SAN. VE TİC. A.Ş., Ankara

Intended purpose, contraindications, warnings and precautions are given in the instructions for use. Search the e-IFU

Design rationale

Dual-lead thread

Two thread starts advance the screw by two pitches for each turn. Depth is therefore reached in fewer turns, and the thread profile is meant to give tactile feedback as it engages bone. QUATRO takes a different route, combining a quad-lead cortical thread with a dual-lead thread below it.

Buttress-thread set screw

A buttress-thread set screw sits in the polyaxial head and is designed to avoid cross-threading when the rod is locked. Final locking is made through the torque-limiting handle, with the anti-torque holding the head. Locking is a one-step mechanism.

Four screw types

Polyaxial screws suit most levels. Listhesis screws carry extended tabs that guide the rod to a displaced vertebra. Cannulated fenestrated screws run over a guide wire, and self-tapping monoaxial screws give a rigid head, for example at the apex of a deformity.

Rods and derotation

Rods are offered in titanium alloy or Cr-Co, with laminar and pedicular hooks and transverse links. ATLAS derotation sleeves attach to the heads of both polyaxial and monoaxial RAPIDFIX screws.

Indications

Stabilisation of spinal segments in the thoracic, lumbar and sacral spine (T4 to S1) as an adjunct to fusion, in skeletally mature patients
Degenerative disc disease
Spondylolisthesis
Trauma (fracture or dislocation)
Spinal stenosis
Curvatures: scoliosis, kyphosis, lordosis
Tumour
Pseudarthrosis
Failed previous fusion

Source: Normmed product catalogue.

Documents for this product

Instructions for usee-IFU search by REF or lot Surgical techniquePDF, on request Product brochurePDF, on request Product catalogueSizes and references CertificatesCE and quality certificates EU declaration of conformityBy e-mail, on request ISO 13485 certificateBy e-mail, on request

Regulatory status

This product belongs to the thoracolumbar fixation system (pedicle screws, set screws, rods, connectors and hooks) named on an EU MDR certificate. SILVER is not covered by this certificate.