Cleared Traditional

AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION (K953720) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953720 · Aesculap, Inc. · Orthopedic device
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Nov 1995
Decision
85d
Days
Class 2
Risk

K953720 is an FDA 510(k) clearance for the AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on November 2, 1995 after a review of 85 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 Aesculap, Inc. devices

Submission Details

510(k) Number K953720 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 09, 1995
Decision Date November 02, 1995
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 238
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K953720.
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K964416 · Synthes (Usa) · Mar 1997
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · Depuy, Inc. · Dec 1996
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · Johnson & Johnson Professionals, Inc. · Nov 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · Codman & Shurtleff, Inc. · Nov 1994
CASPAR TITANIUM ALLOY BONE SCREWS
K936269 · Aesculap, Inc. · Aug 1994