Carlsmed, Inc. · Class II · Cleared Dec 13, 2024
| K-number | K243635 |
| Device name | aprevo® anterior lumbar interbody fusion device with interfixation |
| Applicant | Carlsmed, Inc. |
| Product code | OVD |
| Device class | Class II |
| Decision date | Dec 13, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is a personalized titanium spinal implant designed to stabilize the lumbar spine and facilitate fusion in skeletally mature patients with severe adult spinal deformity. The device features patient-specific geometry developed from CT scans, includes an aperture for bone graft packing, and can be used standalone at one or two spinal levels with integrated screws or with supplemental fixation at higher levels or with greater lordosis.
The device is manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, with screws machined per ASTM F136. Dimensions and design features including height, footprint, angulation, screw configurations, and inserter configurations are similar to predicate devices. The device is provided as single-use, sterile-packed product with an accompanying inserter instrument.
ASTM F3001 (titanium alloy material specification) and ASTM F136 (screw material specification) are cited for materials. ISO and IEC consensus standards are not explicitly mentioned in this summary document.
Substantial equivalence is based on the ALIF-X being identical to predicates in intended use (interbody fusion), manufacturing methods, raw materials (titanium alloy construction), and principle of operation (spinal stabilization and fusion). The device has similar indications for use and comparable technological features—including similar dimensions, footprints, angulation, and screw configurations—to the primary predicate K241477 and additional predicates, supporting SE despite the new standalone indication added in this submission.
View the full FDA submission: accessdata.fda.gov