Cleared Traditional

K252573 - KLS Martin Cranial Implants - MR Conditional (FDA 510(k) Clearance)

Also includes:
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

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252573 · KLS-Martin L.P. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
88d
Days
Class 2
Risk

K252573 is an FDA 510(k) clearance for the KLS Martin Cranial Implants - MR Conditional. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on November 10, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all KLS-Martin L.P. devices

Submission Details

510(k) Number K252573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.