Cleared Traditional

K921256 - LUQUE V SPINAL SYSTEM (FDA 510(k) Clearance)

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

K921256 · Sofamor Danek Mfg., Inc. · Orthopedic device
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May 1993
Decision
428d
Days
Class 2
Risk

K921256 is an FDA 510(k) clearance for the LUQUE V 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 May 18, 1993 after a review of 428 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Sofamor Danek Mfg., Inc. devices

Submission Details

510(k) Number K921256 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 16, 1992
Decision Date May 18, 1993
Days to Decision 428 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 122d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.