Cleared Special

K142558 - Caspian OCT/MESA Mini/DENALI Mini Spinal System

K142558 is an FDA 510(k) clearance for Caspian OCT/MESA Mini/DENALI Mini Spina..., manufactured by K2m. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 102-day FDA review.

K142558 · K2m · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
102d
Days
Class 2
Risk

K142558 is an FDA 510(k) clearance for the Caspian OCT/MESA Mini/DENALI Mini Spinal System. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on December 22, 2014 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142558

510(k) Number K142558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2014
Decision Date December 22, 2014
Days to Decision 102 days
Submission Type Special
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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K142558.
SOLSTICE OCT System
K143249 · Life Spine, Inc. · Apr 2015
SOLSTICE OCT System
K150229 · Life Spine, Inc. · Apr 2015
OASYS System
K142741 · Stryker Corporation · Jan 2015
NEXTGEN ALTIUS OCT SYSTEM
K140734 · Ebi, LLC · Dec 2014
EXPEDIUM Spine System/Synapse System
K142460 · Johnson and Johnson · Oct 2014
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · Synthes USA Products, LLC · Sep 2014
K142558 · Caspian OCT/MESA Mini/DENALI Mini Spinal System
Download PDF FDA Summary K2m