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Spine · Interbody cages

POLAR Cervical PEEK cage

Name: POLAR Cervical PEEK cage
Brand: Normmed

Cervical interbody fusion cage.

EU MDR

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Overview

After a cervical discectomy the disc space has to be held open at a height that decompresses the foramen. The endplates have to stay intact for fusion. POLAR is a PEEK cervical interbody cage whose contoured shape follows the endplate, with tantalum markers for radiographic positioning. The radiolucent PEEK body is MRI-compatible. It is placed through the Smith-Robinson approach and is intended for use with an anterior cervical plate such as TRIMI.

Product group: Spine
System: Interbody cages
Anatomical region: Cervical spine
Material: PEEK with tantalum markers and titanium pins
Device class (EU MDR): III
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

Radiolucent PEEK body

PEEK is radiolucent, so the cage is intended to leave the fusion area clear on imaging. Integrated tantalum markers show its position on fluoroscopy during insertion, which helps the surgeon judge depth and alignment before the holder is released.

Endplate-matched profile

The contoured profile follows the shape of the vertebral endplates to increase contact area.

Teeth and titanium pins

Serrations on the upper and lower surfaces and two titanium pins are designed to give initial fixation and to resist migration. A central opening is packed with graft before insertion.

Depth-set holder

The POLAR holder has a preset depth feature, so the cage is advanced to a defined position under fluoroscopy. Caspar pins and the Caspar retractor keep the segment distracted while the cage is tapped in.

Indications

Anterior cervical intersomatic fusion cages for the treatment of soft and hard disc degenerative conditions, in combination with anterior cervical plates
Traumatic disc lesions
Revision surgery for pseudarthrosis
Anterior cervical interbody fusion at one or two contiguous levels (C2–T1) in skeletally mature patients with degenerative disc disease

Source: Normmed product catalogue.

Documents for this product

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

Regulatory status

Families marked EU MDR are named on EU MDR certificates. The other spine families are CE-marked under the MDD and remain legally marketed under the MDR transition provisions while their MDR certification is ongoing.