Cleared Traditional

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

K252573 · KLS-Martin L.P. · Neurology

Nov 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K252573 is an FDA 510(k) clearance for the 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, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on November 10, 2025, 88 days after receiving the submission on August 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number	K252573 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2025
Decision Date	November 10, 2025
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF