Cleared Traditional

K101084 - CASPIAN SPINAL SYSTEM

K101084 is the FDA 510(k) clearance for CASPIAN SPINAL SYSTEM by K2m, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K101084 · K2m, Inc. · Orthopedic device
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Oct 2010
Decision
168d
Days
Class 2
Risk

K101084 is an FDA 510(k) clearance for the 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 October 4, 2010 after a review of 168 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

Submission Details

510(k) Number K101084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2010
Decision Date October 04, 2010
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K101084.
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · X-Spine Systems, Inc. · Nov 2010
MODIFICATION TO: OASYS SYSTEM
K101183 · Stryker Spine · Nov 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · Pioneer Surgical Technology · Oct 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · Osteomed LP · Aug 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · Nuvasive, Inc. · Jun 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · Alphatec Spine, Inc. · Jun 2010