Cervical Interbody Fusion

TRISTAN® Cervical Interbody Fusion is an implant system which is intended as a disc replacement for a long-term usage for anterior stabilization in the cervical spine from C3 to C7 in patients whose general skeletal growth has ended. The system includes implants of various dimensions, heights and angulations, whereby the unique anatomy of the individual patient can be taken into account. TRISTAN® is implanted via an anterior approach and cervical discectomy and offers the following product-specific benefits: • Form analogous to anatomy in cross-section and sagittal profile, with flat base plate...

Interbody Device System Product-specific benefits Anatomical design Stability Integrity Modularity

TRISTAN® Titanium Properties of TRISTAN® Titanium, PEEK-S and R-PEEK-Ti TRISTAN® Titanium is a solid titanium implant designed for cervical interbody fusion, and is used in degenerative disc diseases and instabilities in the C3-C7 area. Combined with reliable and simple instruments, TRISTAN® Titanium is the ideal solution for cervical Titanium non-sterile/sterile interbody fusion. Only titanium alloy Ti6Al4V (DIN EN ISO 5832-3) is used. The titanium cages are available both as sterile-packed implants and in non-sterile form, stored directly in the implant tray. TRISTAN® PEEK-S TRISTAN® PEEK-S...

Surgical technique Exposing the intervertebral space Inserting the Distraction Pins I Inserting the Distraction Pins II The intervertebral space is opened and resected by fenestration of the anterior longitudinal ligament. The Distraction Pin is inserted into the end of the Pindriver from below until it locks into place by the locking spring located on the Pindriver. Care should be taken to align the hexagonal profile so that the Distraction Pin is correctly positioned in the Pindriver. The Distraction Pins are then placed in the caudal and cranial vertebrae adjacent to the section to be treated....

Surgical technique Expansion of the intervertebral space Assembling the TRISTAN Trial The Retrieval Body Retractor is placed onto the protruding ends of the Distraction Pins from above. The intervertebral space is then carefully expanded by turning the setting wheel (1) on the Retrieval Body Retractor, thereby exposing the intervertebral space as far as the posterior edge. The intervertebral space is fully cleared and disc material is removed. The correct implant size and angulation can be determined under X-ray control using the TRISTAN Trials. To connect the TRISTAN Trial to the Cage Inserter,...

Determining the implant size I Determining the implant size II The TRISTAN Trial is introduced into the disc space, using light hammer taps if necessary. The TRISTAN Trial should fit as snugly as possible in the prepared intervertebral space. If necessary, further preparation of the implant bed should be carried out until the required fit accuracy is obtained. Correct fitting of the TRISTAN Trial is achieved when the anterior edge is positioned around 1-2 mm behind the anterior edge of the vertebral body and the cage length occupies around 4/5 of the anteroposterior expansion of the intervertebral...

Surgical technique Compressing the vertebral bodies Care should be taken to ensure that Tristan Inserter B is screwed in smoothly in order to avoid deforming the thread. If necessary, the orientation of the instrument to the implant should be corrected. To prevent crossthreading while screwing in Tristan Inserter B, first turn the Tristan Inserter B anticlockwise until you clearly feel the thread catch. Tristan Inserter B is then fully screwed into the implant. The implant is introduced into the disc space, using light hammer taps if necessary. If necessary, the implant can be hammered further...

Markers - TRISTAN® PEEK-S and TRISTAN® R-PEEK-Ti in TRISTAN® PEEK-S and TRISTAN® R-PEEK-Ti To ensure the cage is positioned correctly, it must be placed in a central position after insertion into the disc space. The X-ray markers fitted within PEEK implants allow the implant position to be visualised using a fluoroscope. This enables the exact location of the cage to be assessed using X-ray images. Two markers are built into TRISTAN® PEEK-S implants on the posterior implant margin, along with 4 spikes at the lateral anterior implant margin TRISTAN® which also serve as markers. The four anterior...

10° 10 HumanTech - Medical Devices

TRISTAN® Titanium (non-sterile) Item no.

TRISTAN® PEEK-S Item no.

TRISTAN® R-PEEK-Ti (Peek with titanium coating) HumanTech - Medical Devices

TRISTAN Trials 14 HumanTech - Medical Devices

Cage Inserter Cage Inserter with stop Retrieval Body Retractor HumanTech – Medical Devices

Manufacturing and Sales Europe Sales Middle East Sales Latin America HumanTech Spine GmbH İkitelli OSB Tümsan 2. Kısım C-Blok No: 47 TR-34306 Başakşehir İstanbul Rio Mixcoac No. 212-3 Acacias del Valle Del. Benito Juárez C.P. 03240 Mexico, D.F. Mexico Edition 1/2020 – Subject to change