The T-PAL™ Spacer System is a “kidney bean” style implant for use in TLIF surgery, which employs several ease of use features. The implant has pyramidal teeth as well as rails on the surface and a self-distracting bullet nose to facilitate a guided insertion technique. The spacers are offered in two footprints, 11 heights and a lordotic angle of 5° (0° for 7mm height spacers). The unique features include TRACK TECHNOLOGY™ and an articulating inserter which allows for better placement of the spacer through an open or MIS approach.
The T-PAL Spacer applicator features one instrument for the insertion of the spacer and trials. The applicator features a pivoting option for controlled insertion as well as rigid 0° and 80° positioning of the spacer.
The T-PAL Spacer and applicator work in conjunction to allow a Guided Insertion Technique. Trial Spacers can be placed at the final spacer location.
The DePuy Synthes Spine T-PAL 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 T-PAL 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 non-operative treatment.
The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.
Use of the DePuy Synthes Spine T-PAL Spacer implant is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopedic implant.
Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in patients with such conditions must be made by the physician, taking into account the risks versus the benefits to the patient.
Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions. These patients may place undue stresses on the implant during bony healing and may be at higher risk of implant failure.
Prior fusion at the level(s) to be treated.
Any condition not described in the indications for use.
Please refer to the package insert for the full list of indications, contraindications, warnings, and/or precautions.
|TRACK TECHNOLOGY™||Guide and turn the spacer into position offering ease of use|
|T-PAL™ Spacer applicator||Ease of use. One instrument designed for minimally invasive surgery for the spacer and trials offers a simple OR technique. Pivoting and Rigid options allow for controlled insertion facilitated by rails with a secure attachment of the spacer to the applicator for ease of use.|
|Self-distracting bullet nose||Facilitates insertion and allows insertion into tight disc spaces|
|Pyramidal teeth||Provide resistance to spacer migration|
|Connection cylinder||Permits pivoting action of the applicator to reduce complications during insertion|
|Two anterior radiographic marker pins (only in PEEK option)||Enables visualization of the anterior spacer position verifying placement. The 1.4mm diameter pins are located approximately 2mm from the anterior edge of the spacer|
|One radiographic marker pin at tip (only in PEEK option)||Enable visualization of the spacer tip for position control during insertion. The 1.4mm diameter, 5mm long pin is located in the middle of the spacer, and stops at the bullet nose tip of the spacer|
|Materials||PEEK with titanium alloy (Ti-6Al-7Nb) x-ray markers
|Axial window||Accommodates autogenous bone graft to allow fusion to occur through the spacer|
|5° Lordotic angle||Accommodates the natural spine lordotic curve (7mm height is 0°)|
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.