| K-number | K261067 |
| Device name | BEE PLIF Cage |
| Applicant | NGMedical GmbH |
| Product code | MAX |
| Device class | Class II |
| Decision date | Apr 30, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The BEE PLIF Cage is a lumbar interbody fusion device manufactured from titanium alloy via additive manufacturing. It is indicated for interbody fusion in patients with degenerative disc disease at one or two contiguous levels from L2 to S1, used with bone graft and supplemental fixation instrumentation.
The device is manufactured from titanium alloy per ASTM F3001 using additive manufacturing. It features several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal sides are rough to provide increased stability and prevent device movement.
ASTM F3001 (material specification), ASTM F2077 (dynamic compression shear and dynamic torsion testing), and pyrogenicity testing for endotoxin levels.
The subject device is substantially equivalent to the primary predicate (NG Medical BEE PLIF Cages K211413) because they are identical in intended use and similar in technological characteristics, performance specifications, and material composition. Both use identical titanium alloy material with similar manufacturing processes and comparable geometry and sizing.
View the full FDA submission: accessdata.fda.gov