Spine Wave, Inc. · Class II · Cleared Jun 27, 2025
| K-number | K243816 |
| Device name | Testa TP Pivoting Spacer System |
| Applicant | Spine Wave, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jun 27, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Testa TP Pivoting Spacer System is an intervertebral body fusion device designed for spinal fusion procedures in skeletally mature patients with degenerative disc disease of the lumbar spine (L2-S1) at one or two contiguous levels. It is implanted between vertebral bodies to provide support and correction, and must be used with bone graft material and supplemental fixation.
The device features TiCell Nano Advanced Surface Technology, an etched surface with micro and nano-scale features on the superior and inferior latticed surfaces to enhance fusion resistance and migration prevention. The implant is fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.
Static and dynamic axial compression testing per ASTM F2077; static and dynamic compression shear testing per ASTM F2077; subsidence testing per ASTM F2267; particulate and wear analysis per ASTM F1877.
The Testa TP Pivoting Spacer System is substantially equivalent because it has the same intended use as the predicate devices (intervertebral body fusion in skeletally mature DDD patients at L2-S1), and possesses equivalent technological characteristics including design and material composition. Nonclinical testing demonstrates performance data comparable to legally marketed devices, with no new safety or effectiveness issues identified.
View the full FDA submission: accessdata.fda.gov