Cleared Traditional

K031276 - SYNTHES ANTERIOR CERVICAL LOCKING PLATE...

K031276 is the FDA 510(k) clearance for SYNTHES ANTERIOR CERVICAL LOCKING PLATE... by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K031276 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
71d
Days
Class 2
Risk

K031276 is an FDA 510(k) clearance for the SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 2, 2003 after a review of 71 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 K031276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2003
Decision Date July 02, 2003
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 429
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K031276.
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · Encore Medical, L.P. · Sep 2003
CD HORIZON SPINAL SYSTEM
K032265 · Medtronic Sofamor Danek · Aug 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · Aesculap, Inc. · 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
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · Synthes (Usa) · Apr 2003