Medicrea International S.A.S. (Medtronic) · Class II · Cleared Dec 19, 2025
| K-number | K253577 |
| Device name | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) |
| Applicant | Medicrea International S.A.S. (Medtronic) |
| Product code | MAX |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The IB3D™ PL Spinal System is a lumbar interbody fusion device indicated for patients with degenerative disc disease at 1 or 2 contiguous levels from L2 to S1, and for anterior column support in degenerative scoliosis. The system includes a stainless steel reusable inserter instrument that facilitates insertion and rotation of titanium alloy implants between lumbar vertebral bodies. It is used with bone graft and supplemental fixation systems via open or minimally invasive posterior/transforaminal approach.
The subject device has similar fundamental scientific technology, overall design, dimensions, operative principle, intended use, indications, and sterilization as the primary predicate device (IB3D™ PL Spinal System, K241164). The subject device includes an additional component in its design that enhances durability and supports its intended purpose, while remaining substantially equivalent in manufacturing mechanism and material.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov