Cleared Traditional

K921256 - LUQUE V SPINAL SYSTEM

K921256 is an FDA 510(k) clearance for LUQUE V 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 428-day FDA review.

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

FDA 510(k) Submission Details - K921256

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.

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 311
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K921256.
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767 · Buckman Co., Inc. · Jun 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948 · Synthes (Usa) · Jun 1993
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
K924142 · Codman & Shurtleff, Inc. · Jun 1993
ISOLA(R) TANDEM CONNECTOR
K922504 · Acromed Corp. · May 1993
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392 · Acromed Corp. · Dec 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090 · Acromed Corp. · Dec 1992