Divergent screws
Integrated screws leave the cage on diverging paths into the vertebral bodies above and below. The divergent arrangement is intended to resist lateral bending, extension and axial rotation.
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Spine · Interbody cages
ESA ALIF PEEK cage
Anterior lumbar interbody fusion with screw fixation.
EU MDR
Overview
An anterior lumbar cage can use the full width of the endplate. It must be fixed to the vertebral bodies, and the screw path has to be reached through the incision. ESA is a PEEK ALIF cage with integrated bone screws and a screw lock, combining PEEK and titanium in a single implant.
- Product group
- Spine
- System
- Interbody cages
- Anatomical region
- Thoracolumbar spine
- Material
- PEEK with titanium components
- 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
Angled screw holes
The screw holes are angled so that the surgeon can place the screws while bypassing lateral soft tissue.
Self-drilling screws
The bone screws are self-centring, self-drilling and self-tapping. After the initial pilot hole, a screw is placed to stabilise the implant before any further holes are prepared.
Flexible instrumentation
A flexible awl, drill and screw driver are used through a block guide that is fixed to the cage. The flexible set is intended to accommodate steep angles and so to help with screw insertion on steep sacral slopes.
Screw lock and PEEK–titanium design
A locking mechanism holds the screws in the cage and is designed to help prevent pull-out. The implant combines a radiolucent PEEK body with titanium components, and serrations on both endplate surfaces help limit forward movement of the cage.
Indications
- Lumbar and lumbosacral pathologies that may require anterior segmental arthrodesis, including localised symptomatic degenerative disc disease
- Revision surgery for failed decompression syndrome
- Pseudarthrosis
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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