USTOMED Bone Fixation/Bone Augmentation Systems - PIN

The USTOMED Bone Fixation/Bone Augmentation Systems – PIN is a titanium pin designed to temporarily fasten non-absorbable membranes during bone regenerative treatment in dental applications. The pin is inserted into bone, holds the membrane in place for 3–9 months while bone regenerates, and is then removed; it is not intended for permanent implantation.

The device is a Grade 5 titanium alloy pin with a 2.5 mm head diameter and 3 mm length, identical to the predicate device. It contacts tissue and bone, is provided non-sterile for user sterilization by steam, is single-use only, and has the same expected duration of implantation (>30 days, 3–9 months).

Dimensional verification, validation of user reprocessing procedures, mechanical testing per ASTM F543-17, biocompatibility per ISO 10993-1, cytotoxicity per ISO 10993-5, and materials chemical analysis per ISO 10993-18.

The subject device has identical intended use (fastening membranes during bone regeneration), identical technological characteristics (same material, dimensions, contact surfaces, duration, sterility status, and reusability), and the same product code (DZL) as the predicate K201561 Membrane Tack. All design verification and validation testing met acceptance criteria, confirming that no new safety or effectiveness concerns arise from the identical design and intended use.