Cleared Traditional

K242527 - The Karma® Fixation System (FDA 510(k) Clearance)

K242527 · Spinal Elements, Inc. · Orthopedic device

May 2025

Decision

268d

Days

—

Risk

K242527 is an FDA 510(k) clearance for the The Karma® Fixation System. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2025, 268 days after receiving the submission on August 26, 2024.

This device falls under the Orthopedic FDA review panel.

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