Cleared Traditional

K133288 - CASPIAN OCT SPINAL SYSTEM

K133288 is an FDA 510(k) clearance for CASPIAN OCT SPINAL SYSTEM, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K133288 · K2m, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
249d
Days
Class 2
Risk

K133288 is an FDA 510(k) clearance for the CASPIAN OCT 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 July 1, 2014 after a review of 249 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. 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 K2m, Inc. devices

FDA 510(k) Submission Details - K133288

510(k) Number K133288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date July 01, 2014
Days to Decision 249 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
127d slower than avg
Panel avg: 122d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K133288.
EXPEDIUM Spine System/Synapse System
K142460 · Johnson and Johnson · Oct 2014
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · Synthes USA Products, LLC · Sep 2014
CASPIAN SPINAL SYSTEM
K141284 · K2m, Inc. · Jul 2014
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · Zimmer Spine, Inc. · Jun 2014
GIBRALT ROD-TO-ROD CROSS CONNECTORS
K140645 · Exactech Sarasota · Apr 2014
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
K133374 · Pioneer Surgical Technology, Inc. (Rti Surgical, I · Mar 2014