Cleared Traditional

Z-PLATE ANTERIOR FIXATION SYSTEM (K922543) - FDA 510(k) Clearance

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

K922543 · Sofamor Danek Mfg., Inc. · Orthopedic device
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May 1993
Decision
355d
Days
Class 2
Risk

K922543 is an FDA 510(k) clearance for the Z-PLATE ANTERIOR FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 355 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 Sofamor Danek Mfg., Inc. devices

Submission Details

510(k) Number K922543 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 29, 1992
Decision Date May 19, 1993
Days to Decision 355 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 122d · This submission: 355d
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 242
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K922543.
SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE
K925351 · Synthes (Usa) · Nov 1993
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