Life Spine, Inc. · Class II · Cleared Jan 23, 2025
| K-number | K243668 |
| Device name | ProLift Pivot Expandable Spacer System |
| Applicant | Life Spine, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jan 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The ProLift Pivot Expandable Spacer System is an intervertebral body fusion device made from titanium alloy and cobalt chrome. It is used in spinal fusion procedures for skeletally mature patients with degenerative disc disease at one or two contiguous levels (L2-S1) who have failed at least six months of non-operative treatment. The expandable spacer (8–15 mm height) accommodates bone graft and works with supplemental internal fixation systems like pedicle screws.
The device is available in multiple sizes and footprints, fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and cobalt chrome (CO-26Cr-6MO) per ASTM F1537. It features superior and inferior surfaces with teeth to prevent rotation and migration at the vertebral interface. The hollow design allows packing of autograft or allogeneic bone graft and is provided sterile for single use only.
ASTM F136 (titanium alloy specification), ASTM F1537 (cobalt chrome specification), and ASTM F2077 (static compression shear, static axial compression, dynamic compression shear, and dynamic axial compression testing).
The ProLift Pivot Expandable System matches its predicates in design (expandable interbody spacer with bone graft capacity), materials (titanium and cobalt chrome), indications for use (spinal fusion for degenerative disc disease), and function (intervertebral fusion with supplemental fixation). Mechanical performance testing per ASTM F2077 demonstrated performance substantially equivalent to the primary predicate (K190488) and additional predicates, confirming equivalent safety and effectiveness for the same intended use.
View the full FDA submission: accessdata.fda.gov