TRI-matrix® X-Force Implants

TRI-matrix X-Force implants are tissue-level endosseous dental implants for placement in the maxillary or mandibular bone to restore chewing function in edentulous and partially edentulous patients. They support single-stage or two-stage surgical procedures and can be immediately loaded when primary stability is achieved. Implants 18–22 mm long in the maxilla are indicated only for multi-unit splinted restorations using at least two implants.

The subject device features a tapered body, double-lead threads, self-cutting flutes, and a grit-blasted acid-etched (TRI SBA) surface with a pink anodized 1.8 mm transgingival collar. Compared to the predicate, it has a modified thread design suited to immediate placement, a more tapered apical portion with smaller apical diameter, and more aggressive apical cutting flutes. Available body diameters are 3.3, 3.7, 4.1, 4.7, and 5.7 mm with lengths from 8–22 mm (depending on diameter) and platform diameters of 3.7 or 4.5 mm.

Sterilization validation per ISO 17665-1 and ISO 17665-2; biocompatibility per ISO 10993-5 and ISO 10993-12; worst-case, static, and dynamic mechanical testing per ISO 14801.

The indications for use are identical to the primary predicate (K203660), differing only in nomenclature and inclusion of longer implant lengths (18, 20, 22 mm). The dimensional ranges overlap with the predicate except for the extended lengths and one shorter 8 mm option; reference devices K212785 and K230108 support equivalence for these outlier sizes. The subject device uses identical titanium alloy (ASTM F136), identical surface treatment (grit-blast/acid-etch with anodized collar), identical sterilization (gamma irradiation), and identical prosthetic interface (internal connection). Engineering analysis and ISO 14801 mechanical testing demonstrate the modified thread design and tapered apical geometry do not create a new worst-case relative to the predicate with identical connection platform.