Newclip Patient-matched instrumentation non sterile PSI

The Newclip Patient-matched instrumentation non-sterile PSI is a surgical guide device that is 3D printed from polyamide and customized to match a patient's anatomy. It is used to assist surgeons in pre-operative planning and guiding surgical instruments during knee osteotomy procedures (bone-cutting surgeries around the knee), including high tibial lateral and anterior closing osteotomies. The device is provided non-sterile for sterilization by healthcare professionals before use.

The subject device uses the same additively manufactured (3D-printed) polyamide material (PA2200) as the predicate device, manufactured using identical additive manufacturing methods. Both devices use computed tomography (CT) imaging for pre-operative planning. The subject device expands the predicate's scope to include high tibial lateral and anterior closing osteotomies, while maintaining compatibility with the Newclip Activmotion Range implant system.

Not stated in this summary.

Substantial equivalence is established through: (1) identical material composition and manufacturing method compared to predicate K240415; (2) same imaging technique (CT) and target population (adults); (3) shared intended purpose as patient-matched surgical guides for knee osteotomies; and (4) verification and validation activities demonstrating equivalent precision, accuracy, and usability in worst-case design, manufacturing, and simulated surgical use by surgeons of varying experience levels, with results comparable to the predicate device clearance.