prodisc® L Instruments

The prodisc® L Instruments are manual surgical instruments designed for the placement, positioning, and removal of prodisc® L total disc replacement implants in the lumbar spine. The submission seeks clearance for four additional instrument designs: two Hemi Chisel variants (10mm and 12mm sizes with +3mm offset) and two Superior Impactor variants (Medium and Large sizes).

These are new instruments based on similar devices already within the existing prodisc® L instrument set. The submission describes them as variations of established surgical instruments for disc replacement, with the primary design differences being size variants and specific geometric features (chisel offset and impactor dimensions).

Not stated in this summary.

Substantial equivalence is established on the basis that the four new instruments share identical indications for use (placement, positioning, and removal of prodisc® L implants), are manufactured from the same materials as existing instruments, and employ the same functional design principles as predicate instruments already cleared under K242869. Because they are size and geometry variants of existing cleared instruments within the same instrument family, they perform substantially equivalent functions without introducing new risks or design principles.