Cleared Special

K093670 - MODIFICATION TO: OASYS SYSTEM

K093670 is the FDA 510(k) clearance for MODIFICATION TO: OASYS SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code MNH) cleared through the Special 510(k) pathway after a 111-day FDA review.

K093670 · Stryker Spine · Orthopedic device
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Mar 2010
Decision
111d
Days
Class 2
Risk

K093670 is an FDA 510(k) clearance for the MODIFICATION TO: OASYS SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on March 18, 2010 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 K093670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2009
Decision Date March 18, 2010
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K093670.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678 · Spineart · Jul 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706 · L & K Biomed Co., Ltd. · Jul 2010
MIS SYSTEM
K100605 · Spine Wave, Inc. · Jun 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · Spine Wave, Inc. · Feb 2010
FORTEX PEDICLE SCREW SYSTEM
K090224 · X-Spine Systems, Inc. · Jul 2009
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009