Adler Ortho S.P.A · Class II · Cleared Jan 13, 2025
| K-number | K241059 |
| Device name | Pantheon Proximal Femur Reconstruction (PFR) System |
| Applicant | Adler Ortho S.P.A |
| Product code | LPH |
| Device class | Class II |
| Decision date | Jan 13, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3358 |
The Pantheon Proximal Femur Reconstruction (PFR) System is a modular hip reconstruction device designed for revision hip surgery to address severe proximal femoral bone loss due to infection, fracture, failed total hip arthroplasty, or bone tumor. It consists of various Ti6Al4V components (proximal bodies, stems, collars, screws, and plates), CoCrMo or ceramic femoral heads, cross-linked polyethylene acetabular inserts, and a titanium acetabular cup system that can be combined to replace the hip joint and reconstruct bone defects.
The Pantheon PFR System uses Ti6Al4V alloy for most structural components manufactured via additive manufacturing, with CoCrMo or Biolox Delta ceramic femoral heads and cross-linked UHMWPE acetabular inserts. It features modular 12/14 taper connections for femoral heads, female conical tapers for shaft and stem connections, and a range of sizes for proximal bodies (L50–L70 mm), stems (L115), bridging collars, and acetabular cups (sizes 48–64). The device employs similar materials, geometries, and modular design principles as its predicate devices.
ISO 7206-6 (neck fatigue), ISO 7206-4:2010 (distal stem fatigue), ASTM F1875-98 (corrosion), ASTM F2009-20 and ISO 7206-10:2018 (modular and taper disassembly), EN ISO 21535:2017 (range of motion), ASTM F2582-20 (impingement), ISO 7206-13 and ASTM F2345 (ceramic head testing), ASTM F3090-20 (acetabular cup fatigue), ASTM F1820-13 (insert testing), ISO 14242 (insert wear), ASTM F543 (acetabular screw testing).
The subject device and predicate devices share the same intended use (proximal femur reconstruction in revision hip surgery), are made of substantially similar materials (Ti6Al4V, CoCrMo, ceramic, cross-linked UHMWPE), employ comparable modular designs and connection systems, and offer similar geometries and size ranges. Comprehensive biomechanical and performance testing demonstrates the device meets or exceeds predicate device performance across fatigue, corrosion, disassembly, wear, and safety metrics, establishing that technological characteristics and safety/effectiveness profiles are substantially equivalent.
View the full FDA submission: accessdata.fda.gov