Cleared Traditional

K890192 - LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET

K890192 is an FDA 510(k) clearance for LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K890192 · Danek Medical, Inc. · Orthopedic device
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Jan 1990
Decision
351d
Days
Class 2
Risk

K890192 is an FDA 510(k) clearance for the LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 351 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K890192

510(k) Number K890192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 04, 1990
Days to Decision 351 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 122d · This submission: 351d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K890192.
DANEK PRECISION ROD SET
K896254 · Danek Medical, Inc. · Jun 1990
AXIAL AND OFFSET CROSSLINK PLATES
K896740 · Danek Medical, Inc. · Feb 1990
HSC UNIT ROD
K896603 · Danek Medical, Inc. · Jan 1990
ACROMED DOUBLE SUBLAMINAR WIRE
K895413 · Acromed Corp. · Nov 1989
ACROMED BEADED SUBLAMINAR WIRE
K895439 · Acromed Corp. · Nov 1989
ACROMED BUTTON SPINAL WIRE
K895441 · Acromed Corp. · Nov 1989