Cleared Traditional

K904520 - RAY SACRAL FIXATION SYSTEM

K904520 is an FDA 510(k) clearance for RAY SACRAL FIXATION SYSTEM, 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 387-day FDA review.

K904520 · Danek Medical, Inc. · Orthopedic device
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Oct 1991
Decision
387d
Days
Class 2
Risk

K904520 is an FDA 510(k) clearance for the RAY SACRAL FIXATION SYSTEM. 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 October 25, 1991 after a review of 387 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 - K904520

510(k) Number K904520 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 03, 1990
Decision Date October 25, 1991
Days to Decision 387 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
265d slower than avg
Panel avg: 122d · This submission: 387d
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 K904520.
CROSSLINK SYSTEM
K911663 · Synthes (Usa) · Mar 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · Danek Medical, Inc. · Jan 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · Zimmer, Inc. · Jan 1992
CROSSLINK PLATE
K911307 · Danek Medical, Inc. · Oct 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · Danek Medical, Inc. · Sep 1991
TSRH OPEN HEAD BONE SCREW
K911319 · Danek Medical, Inc. · Sep 1991