FDA cleared the KLS Martin Pure Pectus System from KLS-Martin L.P. on Dec 11, 2025 under K250988, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on Mar 31, 2025. The decision came 255 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
KLS-Martin L.P. has 4 other decisions in the tracker over the last 12 months: K253660 (KLS Martin Pure Pectus System), K254162 (KLS Martin Ixos System), K250865 (KLS Martin IPS Forearm System), K252573 (KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE).