NEXUS® Hip Stem

The NEXUS Hip Stem is a titanium alloy hip prosthesis designed for total hip arthroplasty to relieve pain and improve hip function in skeletally mature patients. It is intended for treating degenerative joint diseases (both inflammatory and non-inflammatory), correcting functional deformity, and revision procedures where prior treatments have failed. The stem features titanium plasma spray and hydroxyapatite coatings for uncemented implantation.

The device is manufactured from titanium alloy (Ti6Al4V per ASTM F620) with titanium plasma spray coating (ASTM F1580) and hydroxyapatite coating (ASTM F1185). It has the same shape, size range, collar variants, neck lengths, and offsets as the primary predicate device with comparable femoral head connections. It comes in collared and collarless options, sizes 0 through 12, with standard and high offsets.

Range of Motion Analysis (ISO 21535:2023 + A1:2016), Proximal Fatigue (ISO 7206-6), Distal Fatigue (ISO 7206-4), Impingement Performance Analysis (ASTM F2582-20), Magnetic Resonance Testing (ASTM F2182-19 and FDA Guidance for Radiofrequency-Induced Heating), and MRI Environmental testing (ASTM F2052-21, ASTM F2119-07).

The subject device shares identical material composition, principle of operation, and physical design features (shape, size range, collar variants, neck lengths, offsets, femoral head compatibility) with the primary predicate device PROFEMUR Gladiator Thin HA Classic Hip Stem. All performed non-clinical tests met applicable acceptance criteria and demonstrated substantial equivalence. Since the devices are materially and functionally identical with the same intended use, the NEXUS Stem is expected to perform as safely and effectively as its predicates.