Cleared Traditional

K910681 - SIMMONS PLATING SYSTEM

K910681 is the FDA 510(k) clearance for SIMMONS PLATING SYSTEM by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K910681 · Smith & Nephew Richards, Inc. · Orthopedic device
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Oct 1991
Decision
231d
Days
Class 2
Risk

K910681 is an FDA 510(k) clearance for the SIMMONS PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K910681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1991
Decision Date October 04, 1991
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K910681.
KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV
K923703 · Acromed Corp. · May 1993
AESCULAP TITANIUM BONE PLATES
K913730 · Aesculap, Inc. · Mar 1992
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)
K901507 · Kirschner Medical Corp. · Jan 1992
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · Acromed Corp. · Sep 1991
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · Acromed Corp. · Nov 1988
OEC/REZAIAN SPINAL FIXATOR
K841189 · Orthopedic Equipment Co., Inc. · May 1984