Cleared Traditional

K914269 - EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO

K914269 is an FDA 510(k) clearance for EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR S..., manufactured by Scientific Spinal , Ltd.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K914269 · Scientific Spinal , Ltd. · Orthopedic device
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Dec 1991
Decision
85d
Days
Class 2
Risk

K914269 is an FDA 510(k) clearance for the EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Scientific Spinal , Ltd. (Baltimore, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scientific Spinal , Ltd. devices

FDA 510(k) Submission Details - K914269

510(k) Number K914269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1991
Decision Date December 18, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 410
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K914269.
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
RAY SACRAL FIXATION SYSTEM
K904520 · Danek Medical, Inc. · Oct 1991
CROSSLINK PLATE
K911307 · Danek Medical, Inc. · Oct 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · Danek Medical, Inc. · Sep 1991