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

Submission Details

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.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 46
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K242527.
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025
Arthrex Spine Compression FT Screw
K250920 · Arthrex, Inc. · May 2025
AERO MIS Facet Fusion System
K243865 · Aurora Spine · Mar 2025
Ion 3D
K243265 · SurGenTec, LLC · Dec 2024
zLOCK Lumbar Facet Fixation System
K242650 · Zygofix , Ltd. · Sep 2024