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Spine · Motion preservation

D-FLEX Titanium cervical disc prosthesis

Cervical disc arthroplasty.

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D-FLEX Titanium cervical disc prosthesis

Overview

D-FLEX is a cervical disc prosthesis for replacing a diseased or bulging disc while keeping motion at the operated level. Two titanium endplates enclose a compressible silicone core, and the prosthesis is supplied pre-assembled as one component. The endplates are contoured to the vertebral surface and carry titanium blades for fixation. It is placed after a complete discectomy with the dedicated cervical disc instrument set.

Product group
Spine
Anatomical region
Cervical spine
Material
Titanium endplates with silicone core
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

Titanium and silicone

Two titanium endplates enclose a compressible silicone core. The core is intended to absorb load between the vertebrae, while the titanium faces make the contact with bone. This material split is the main difference from D-MOTION, which is made entirely of PEEK.

Motion at the operated level

The design is intended to keep flexion, extension, lateral bending and axial rotation. Maximum angles are 7° for flexion and extension, 7° for lateral bending and 10° for rotation. These are design limits of the implant and not a forecast of any patient's range of motion.

One pre-assembled component

The prosthesis arrives assembled, so there is no intraoperative assembly step. It is held in the dedicated disc prosthesis holder and seated with light hammer taps.

Contoured endplates with blades

The endplates follow the anatomy of the vertebral surface to give broad contact, and titanium blades are intended to resist migration.

Indications

  • Symptomatic cervical disc disease, defined as neck or arm (radicular) pain and/or a functional or neurological deficit, with at least one of the following confirmed by imaging (CT, MRI or X-ray): herniated nucleus pulposus, spondylosis (presence of osteophytes) or loss of disc height.
  • Single- or two-level cervical disc arthroplasty from C3 to C7 in skeletally mature patients

Source: Normmed product catalogue.

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.

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