Cleared Special

K101183 - MODIFICATION TO: OASYS SYSTEM

K101183 is the FDA 510(k) clearance for MODIFICATION TO: OASYS SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 195-day FDA review.

K101183 · Stryker Spine · Orthopedic device
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Nov 2010
Decision
195d
Days
Class 2
Risk

K101183 is an FDA 510(k) clearance for the MODIFICATION TO: OASYS SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 9, 2010 after a review of 195 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. 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.

View all Stryker Spine devices

Submission Details

510(k) Number K101183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date November 09, 2010
Days to Decision 195 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
73d slower than avg
Panel avg: 122d · This submission: 195d
Pathway characteristics
Modification to existing cleared device.

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 K101183.
SP-FIX SPINOUS PROCESS FIXATION PLATE
K102195 · Globus Medical, Inc. · Jan 2011
CASPIAN SPINAL SYSTEM
K103232 · K2m, Inc. · Jan 2011
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · X-Spine Systems, Inc. · Nov 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · Pioneer Surgical Technology · Oct 2010
CASPIAN SPINAL SYSTEM
K101084 · K2m, Inc. · Oct 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · Osteomed LP · Aug 2010