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

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.

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