Category: Lumbar Degenerative
The OPAL™ Spacer is a versatile Interbody fusion device with two implant offerings to accommodate a traditional straight implant insertion and a less invasive insert and rotate technique. The Revolve Spacers are designed for an insert and rotate technique and have a beveled edge that allows for rotating the cages 90 degrees in situ providing intervertebral distraction.
The OPAL Spacer incorporates a bullet-nose for self distraction during insertion, three lengths to accommodate both a TLIF and PLIF applications, pyramidal teeth to resist implant migration.
The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of Interbody fusion combined with supplemental fixation.* The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
*The OPAL Spacer is intended to be used with DePuy Synthes supplemental fixation, e.g. TSLP, ATB, ANTEGRA, PANGEA, USS (including CLICK’X) and USS Small Stature.
|Bullet nose||Ease of insertion, minimizes damage to endplate, ability to treat collapsed disc spaces|
|Multiple approach options||Accommodates preference for a traditional straight design or an insert-and-rotate option in one product offering|
|Beveled edge of revolve cage||Revolve cage can be rotated 90 degrees in situ providing higher distraction with smaller insertion profile|
|Pyramidal teeth||Provides resistance to implant migration|
|Two radiographic marker pins||Provides visualization of the implant positioning within the disc spaces|
|PEEK material||Allows clear assessment of fusion under fluoroscopic imaging|
|Axial canal||Accommodates autogenous bone graft to allow fusion to occur through the spacer|
|Two implant insertion options||
Straight inserter allows for direct in-line control of implant
Pistol grip design offers easier visualization through minimally invasive technique
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.