SwissMembrane X; SwissMembrane X Socket

SwissMembrane X and SwissMembrane X Socket are resorbable collagen membranes made from porcine collagen used in guided tissue and bone regeneration procedures. They are intended for dental applications including implant augmentation, ridge augmentation, bone defect filling, and periodontal regeneration in various clinical scenarios.

Both devices are manufactured from porcine collagen without cross-linking, sterilized by gamma irradiation, and provided as single-use products. SwissMembrane X is available in rectangular and trapezoid shapes in three sizes (13x25 mm, 25x15/25 mm, 30x25/40 mm), while SwissMembrane X Socket is a pre-shaped variant (14x24 mm). The predicate Geistlich Bio-Gide® products share identical material, sterilization, and manufacturing methods, with comparable size ranges and an identical pre-shaped variant.

Not stated in this summary.

Substantial equivalence is established because the subject devices have identical indications for use as the predicate devices, use identical porcine collagen material and gamma sterilization, and fall within the range of size configurations already cleared under the predicate. The applicant leveraged biocompatibility, sterilization, shelf-life, packaging validation, and clinical performance data from the predicate device (K212463) to demonstrate no new worst-case configuration exists, making additional non-clinical testing unnecessary for this product line extension.