Cleared Special

K093534 - MODIFICATION TO CASPIAN SPINAL SYSTEM

K093534 is an FDA 510(k) clearance for MODIFICATION TO CASPIAN SPINAL SYSTEM, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 30-day FDA review.

K093534 · K2m, Inc. · Orthopedic device
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Dec 2009
Decision
30d
Days
Class 2
Risk

K093534 is an FDA 510(k) clearance for the MODIFICATION TO CASPIAN SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on December 16, 2009 after a review of 30 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all K2m, Inc. devices

FDA 510(k) Submission Details - K093534

510(k) Number K093534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2009
Decision Date December 16, 2009
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K093534.
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · Alphatec Spine, Inc. · Jun 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · Lanx, Inc. · Apr 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · Pioneer Surgical Technology · Feb 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656 · Lanx, Inc. · Nov 2009
SENTINEL SPINAL SYSTEM
K090343 · Life Spine · Aug 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · Synthes (Usa) · Jul 2009