BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

The BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices designed to reattach soft tissue to bone. They consist of a suture anchor with pre-attached non-absorbable suture(s) assembled to an insertion device, used arthroscopically for orthopedic repairs including rotator cuff tears, labral repairs, ligament reconstructions, and tendon repairs across the shoulder, hip, knee, foot/ankle, and elbow/wrist/hand.

The subject device is identical in design to the predicate device K152566, with the same anchor material (100% PEEK), suture material (UHMWPE), inserter materials (17-4 PH stainless steel shaft, polycarbonate and ABS handle), sterilization method (EtO), shelf life (5 years), and MR safety profile. The only modification is packaging change from a Tyvek pouch to thermoformed PETG trays with PETG retainers and Tyvek lid.

Not stated in this summary.

Substantial equivalence is established because the subject device has identical intended use (soft tissue reattachment to bone), identical indications for use across multiple anatomical sites, and identical design and materials to predicate K152566. The packaging modification from Tyvek pouches to PETG thermoformed trays represents only a manufacturing change that does not affect device function, sterilization, or sterile barrier effectiveness. Non-clinical testing confirmed the packaging design, usability, and material stability met all specifications, raising no new safety or effectiveness concerns.