K-numberK251718
Device nameArTT Augments and Buttresses and Bone Screws
ApplicantLima Corporate S.P.A.
Product codeLPH
Device classClass II
Decision dateAug 29, 2025
DecisionSubstantially Equivalent
Regulation888.3358
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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.

Test standards cited

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.

Substantial equivalence argument

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.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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