Cleared Traditional

K091159 - SYNTHES ORACLE PLATE

K091159 is the FDA 510(k) clearance for SYNTHES ORACLE PLATE by Synthes Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K091159 · Synthes Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
80d
Days
Class 2
Risk

K091159 is an FDA 510(k) clearance for the SYNTHES ORACLE PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on July 10, 2009 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes Spine devices

Submission Details

510(k) Number K091159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2009
Decision Date July 10, 2009
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K091159.
LIFE SPINE LUMBAR PLATE SYSTEM
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XTEND ANTERIOR CERVICAL PLATE SYSTEM
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TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · Globus Medical, Inc. · Aug 2009
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
K091253 · K2m, Inc. · Jun 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071 · Nuvasive, Inc. · May 2009
PIONEER LUMBAR PLATE SYSTEM
K090222 · Pioneer Surgical Technology · Apr 2009