Cleared Traditional

SIMMONS PLATING SYSTEM (K910681) - FDA 510(k) Clearance

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

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
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 239
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K910681.
SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE
K926453 · Synthes (Usa) · Oct 1993
SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
K922855 · Synthes (Usa) · Jun 1993
AESCULAP TITANIUM BONE PLATES
K913730 · Aesculap, Inc. · Mar 1992
BRADFORD SPINAL FRACTURE FIXATION SYS
K831982 · Depuy, Inc. · Sep 1983
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · Zimmer, Inc. · Oct 1980
D.T.T. LOCK SCREW INSERTER
K790941 · Depuy, Inc. · May 1979