Cleared Traditional

K030866 - SYNTHES ANTERIOR CSLP SYSTEM

K030866 is the FDA 510(k) clearance for SYNTHES ANTERIOR CSLP SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K030866 · Synthes (Usa) · Orthopedic device
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Apr 2003
Decision
30d
Days
Class 2
Risk

K030866 is an FDA 510(k) clearance for the SYNTHES ANTERIOR CSLP SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on April 18, 2003 after a review of 30 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 (Usa) devices

Submission Details

510(k) Number K030866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2003
Decision Date April 18, 2003
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 430
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K030866.
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · Synthes (Usa) · Jul 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · Encore Medical, L.P. · May 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · Blackstone Medical, Inc. · Apr 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965 · Blackstone Medical, Inc. · Mar 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · Medtronic Sofamor Danek · Feb 2003
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · Depuyacromed · Dec 2002