Lima Corporate S.P.A. · Class II · Cleared Aug 29, 2025
| K-number | K251718 |
| Device name | ArTT Augments and Buttresses and Bone Screws |
| Applicant | Lima Corporate S.P.A. |
| Product code | LPH |
| Device class | Class II |
| Decision date | Aug 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3358 |
The ArTT Augments and Buttresses are titanium bone augmentation devices used in hip replacement surgery to address segmental acetabular bone deficiencies as an alternative to structural allograft. They attach cementless to bone but are cemented to the mating acetabular cup. The device also includes titanium bone screws for fixation.
The ArTT Augments and Buttresses are 3D-printed from Ti6Al4V titanium with available sizes in 9 diameters (50-66mm) and 3 eccentricities. Buttresses come in 3 diameters, 3 heights, and 3 configurations. Bone screws are Ti6Al4V with multiple lengths for cancellous or cortical bone fixation. Unlike the Trabecular Metal predicate (tantalum-based), ArTT uses titanium; similar to the DePuy Gription predicate.
ASTM F543 (bone screw torsional properties, driving torque, and pull-out load testing), ISO 5832-3 (titanium material standard), and ASTM F1472 (titanium alloy specification). Fretting fatigue testing was performed per internal protocol on worst-case component constructs.
ArTT shares identical fixation methods (uncemented to bone, cemented to cup) and principle of operation with the Trabecular Metal predicate. Both are available in similar size ranges, sterilely provided, and serve the same clinical purpose. ArTT's titanium composition is acceptable because DePuy's cleared Gription system uses pure titanium augments. Mechanical testing confirmed performance equivalence to the predicate despite material differences.
View the full FDA submission: accessdata.fda.gov