FORZA Ti Spacer System

The FORZA Ti Spacer System with NanovateTechnology has been developed to enhance posterior & transforaminal lumbar procedures with a 3D-printed titanium lumbar interbody designed with a functional gradient porous structure. The FORZA Ti implant has an optimized porosity and pore size which creates a 3D porous surface designed to help facilitate bone ingrowth.** The FORZA Ti Spacer System offers eight footprints, parallel and lordotic angles, heights from 6mm-14mm in one- millimeter increments to address multiple patient anatomies.

Product Highlights

  • Large opening for packing bone grafting material
  • Bulleted nose to assist with distraction
  • 3D porous titanium with macro, micro, and nano-scale surface features
  • The nano-scale surface has been shown to increase proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells in vitro*
  • 3D-printed titanium endplates with 400 micron pores and 50% porosity are designed to help facilitate bone ingrowth**
  • The endplates consist of interconnected gyroid structures analogous in form to trabecular bone which provide an open porous environment
  • Functional gradient porous structure with 80% porosity at the midline of the implant allows for increased fluoroscopic visualization

Indications

The FORZA Ti 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 Ti 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 Ti Spacer System.​

Contraindications

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

  • With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection
  • With rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation
  • 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
  • With prior fusion at the level to be treated
  •  Any circumstances not listed under the heading indications

Footnotes

*In vitro performance may not be representative of clinical performance
**As suggested in an in-vivo ovine lumbar spinal fusion model

Instructions For Use