Cleared Traditional

K925351 - SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE

K925351 is an FDA 510(k) clearance for SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K925351 · Synthes (Usa) · Orthopedic device
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Nov 1993
Decision
379d
Days
Class 2
Risk

K925351 is an FDA 510(k) clearance for the SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE. 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 November 5, 1993 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K925351

510(k) Number K925351 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 22, 1992
Decision Date November 05, 1993
Days to Decision 379 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 122d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K925351.
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · Codman & Shurtleff, Inc. · Nov 1994
ANTERIOR SPINE SYSTEM
K934429 · Buckman Co., Inc. · Oct 1994
CASPAR TITANIUM ALLOY BONE SCREWS
K936269 · Aesculap, Inc. · Aug 1994
SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE
K926453 · Synthes (Usa) · Oct 1993
SENTRY ANTERIOR SPINAL SYSTEM
K930807 · Sofamor Danek Mfg., Inc. · Oct 1993
SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
K922855 · Synthes (Usa) · Jun 1993