Cleared Traditional

K920546 - PARAGON POSTERIOR SPINAL SYSTEM

K920546 is an FDA 510(k) clearance for PARAGON POSTERIOR SPINAL SYSTEM, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K920546 · Sofamor Danek Mfg., Inc. · Orthopedic device
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Jan 1993
Decision
350d
Days
Class 2
Risk

K920546 is an FDA 510(k) clearance for the PARAGON POSTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

FDA 510(k) Submission Details - K920546

510(k) Number K920546 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 06, 1992
Decision Date January 21, 1993
Days to Decision 350 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 122d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 314
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K920546.
ISOLA(R) TANDEM CONNECTOR
K922504 · Acromed Corp. · May 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672 · Sofamor Danek Mfg., Inc. · May 1993
TSRH CENTRAL POST HOOKS
K925811 · Sofamor Danek Mfg., Inc. · May 1993
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392 · Acromed Corp. · Dec 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090 · Acromed Corp. · Dec 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · Kirschner Medical Corp. · Aug 1992