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FORZA® PTC Spacer System

Description

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PRODUCT DESCRIPTION​​

The FORZA PTC Spacer System has been designed to help optimize Transforaminal Lumbar Interbody Fusion
(TLIF), Posterior Lumbar Interbody Fusion (PLIF) and Oblique Lumbar Interbody Fusion procedures with surgeon designed implants and instruments. FORZA PTC Spacers offer a unique technology that combines PEEK and titanium into a porous interbody solution for the lumbar spine. This PEEK/Titanium hybrid is designed with a 3D porous endplate that allows the patient bone to grow into its surface creating a bond between the implant and the patient bone.​


 
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​​PHYSICIAN BENEFITS​

  • 3D printed porous titanium endplates are designed to allow the patient's bone to grow into the porous plate
  • PEEK core to obtain imaging properties while assessing fusion
  • Threaded connection to the Implant Inserter with rail grooves for a secure hold
  • Bulleted nose to assist with distraction and ease of insertion​
  • Vertical tantalum marker 1mm from the end and titanium plates for clear in-situ implant positioning
  • Large opening for packing bone grafting material
  • Multiple implant options to enable various surgical solutions

Indication

Indications

The FORZA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The FORZA PTC Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.​

Contraindications

The FORZA PTC Spacer System, as with other orthopedic implants, is contraindicated for use in patients:

  1. With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection
  2. With rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation
  3. With conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient
  4. With prior fusion at the level to be treated
  5.  Any circumstances not listed under the heading indications

Support Materials

Clinical References

Resources

Instructions for Use