Cleared Traditional

K242527 - The Karma® Fixation System

K242527 · Spinal Elements, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
268d
Days
-
Risk

K242527 is an FDA 510(k) clearance for the The Karma® Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2025 after a review of 268 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinal Elements, Inc. devices

FDA 510(k) Submission Details - K242527

510(k) Number K242527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date May 21, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 68
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K242527.
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Arthrex Spine Compression FT Screw
K250920 · Arthrex, Inc. · May 2025
AERO MIS Facet Fusion System
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Ion 3D
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zLOCK Lumbar Facet Fixation System
K242650 · Zygofix , Ltd. · Sep 2024