Surgical Technique Guide 70-042, Rev. B R NEXXT MATRIXX® TLIF / TLIF Oblique Interbodies

Nexxt Matrixx® TLIF / TLIF Oblique Interbodies Patient Positioning Exposure of Operative Level(s) Discectomy Distraction Decompression Endplate Preparation Implant Size Selection Graft Material Placement Implant Preparation and Insertion Insert and Rotate Technique Implant Removal Device Description Indications/Contraindications Warnings and Precautions Nexxt Matrixx® Lumbar Implants Nexxt Matrixx® Lumbar Instruments Caution: Federal law (USA) restricts this device to sale and use by, or on the order of, a physician.

NEXXT MATRIXX® SYSTEM Nexxt Matrixx® straight and curved Interbodies may be used in posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), or transforaminal posterior lumbar interbody fusion (tPLIF) procedures utilizing supplemental internal fixation such as the Nexxt Spine Inertia® Pedicle Screw System, Inertia® MIS Pedicle Screw System, or Facet Fixx® Screw System. PATIENT POSITIONING Following adequate general anesthesia, the patient is placed in the prone position on a radiolucent spine table (Fig. 1). Particular attention is applied to the positioning of...

DISTRACTION Effective distraction aids in removal of the superior articular process, decompression of the neuroforamen, preparation of the disc space and insertion of the Implant. This may be accomplished through several techniques: pedicle screw distraction, distraction between boney elements, and/or distraction with Paddle Distractors (Fig. 5). DECOMPRESSION Utilizing osteotomes and rongeurs, a small section of the lamina and facet(s) should be removed to create an appropriately sized bony window for access to the targeted disc space (Fig. 6). Preserve decorticated bone to pack in or around...

ENDPLATE PREPARATION Access to the disc space is achieved through an annulotomy made lateral to the posterior longitudinal ligament. Using a scalpel, vertical cuts should be made parallel to the dura and laterally in the foramen between the superior and inferior endplate. Additional cuts extend horizontally along the endplates, connecting the vertical cuts. The annulus and any accessible disc material are removed with interspace shavers, rongeurs, curettes, etc. (Fig. 7). The discectomy is complete once superficial layers of the entire cartilaginous endplates are removed and bleeding bone is...

IMPLANT SIZE SELECTION (CONTINUED) Insert desired Trial into the intervertebral disc space using gentle impaction of a mallet or Slap Hammer. The Slap Hammer includes laser etched steps (Attach, Drop, and Rotate) for attachment of the Trial (Fig 10). Fluoroscopy can assist in confirming the fit and geometry of the Trial. If the Trial appears too loose or too tight, try the next larger or smaller size until the most secure fit is achieved. The Slap Hammer can be used to facilitate the removal of the Trial from the intervertebral disc space. To use, apply an upward force to the Slap Hammer. Repeat...

IMPLANT PREPARATION AND INSERTION (CONTINUED) For TLIF Oblique, mate the Alignment Keys to the implant (Fig. 12) and commence insertion by turning the knob on the threaded shaft component clockwise. For TLIF, place the end of the Implant into the circular cup and thread into the Implant by turning the knob on the threaded shaft component clockwise (Figure 13). Confirm the implant is securely attached but DO NOT overtighten. GRAFT MATERIAL PLACEMENT Prior to insertion, pack the center cavity of the implant with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft....

IMPLANT PREPARATION AND INSERTION (CONT.) Turn the knob on the threaded inserter shaft in a counterclockwise direction to release the implant from the Inserter (Fig. 15). If the Implant requires further adjustment, a Tamp may be used to carefully manipulate into desired position. Complete the procedure by following the surgical technique for the specific device to be used as supplemental fixation, such as the Nexxt Spine Inertia® Pedicle Screw System, Inertia® MIS System, or Facet Fixx® Screw System. OPTIONAL: Insert and Rotate Technique The Insert and Rotate Technique provides potential for...

NOTES: -Tactile feedback during Implant rotation reduces potential for overstretching/oversizing. Primary distraction takes place in the intervertebral space. The distraction produced by the width of the Implant results in effective tensioning of the anterior and posterior longitudinal ligaments without damaging them. This rotation step also ensures that the neural structures remain protected throughout the implantation process. -The Insert & Rotate Technique reduces the need for expandable Implant and their associated graft containment issues. IMPLANT REMOVAL Attach either the Inserter or Universal...

DEVICE DESCRIPTION Nexxt Matrixx® is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the Nexxt Matrixx® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the Nexxt Matrixx® solid...

NEXXT MATRIXX® INSTRUMENT PRODUCT NUMBERS I54-XXL-XX TLIF Oblique Trial Lordotic* I54-XXP-XX TLIF Oblique Trial Parallel I21-09-01, Implant Tamp, 90 degree I56-XXL-XX TLIF Trial Lordotic I21-09-02, Implant Tamp, Straight I56-XXP-XX TLIF Trial Parallel* I35-50-01L, Universal Remover, Long I15-01-01, TLIF, Implant Inserter I54-01-01 TLIF Oblique Inserter I10-01-43 T-Handle, Silicone, Hudson Connect I10-01-34 T-Handle, Silicone, Hudson Connect* I54-20-01 Nexxt Matrixx® Slap Hammer NEXXT MATRIXX® TLIF / TLIF Oblique