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Spine · Cervical

TRIMI Anterior cervical plate system

Anterior cervical plate fixation. The Sterile Cervical Plate System is named on an EU MDR certificate.

EU MDR

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TRIMI Anterior cervical plate system

Overview

Anterior cervical plating stabilises one to four levels of the cervical spine. The plate lies against the prevertebral soft tissue, so its profile matters. Variable-angle screws are held by a quarter-turn mechanical lock that has no ring to fatigue. The system is supplied with plate screws and larger-diameter revision screws.

Product group
Spine
System
Cervical
Anatomical region
Cervical spine
Material
Titanium
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

Forged titanium plate

The plate is forged from a titanium billet, a process chosen for fatigue resistance and structural density. The aim is high strength at low thickness. The outer rim is rounded, which is intended to make the plate less aggressive against the soft tissue lying over it.

Two pre-set curves

Each plate carries an anatomical radius across the vertebral body and a lordotic radius along the spine. It is designed to sit flush without intraoperative bending. When more or less lordosis is wanted, a plate bender is used. Its channels protect the lock region, because bending at the lock would impair its action.

Quarter-turn central lock

A central lock covers the two screws of each level. It turns through 90° with the plate screw driver and gives visual and tactile confirmation that it is closed. The mechanism is mechanical, with no ring that can fatigue under high insertion torque, and screws can be unlocked, removed and repositioned in revision. When the lock is closed, the screw heads lie flush or recessed beneath it.

Variable screw angulation

Screws can be angled from −2° to 22° in the cephalad–caudal plane and from −4° to 10° in the medial–lateral plane. A double sleeve prepares both holes at one end of the plate together. An angled sleeve awl reaches the cephalad trajectories without being blocked by the chin or mandible.

Open view of the field

Fixation pin holes are positioned to keep the surgical field unobstructed and give a clear line of sight during screw insertion. The plate can be aligned to the endplates under direct sight while it is held with fixation pins. A midline alignment notch helps centring.

Depth-controlled drilling

The drill has an integrated depth stop that limits drilling depth by contacting the sleeve. The depth is therefore set before drilling instead of being judged during it.

Indications

  • Anterior plating of the cervical spine (C2–T2) for internal fixation in the treatment of instabilities associated with fractures and dislocations
  • Instabilities associated with degenerative diseases
  • Instabilities associated with tumours
  • Instabilities associated with partial or total spondylectomy

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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