Cleared Traditional

K904446 - CASF (TM) (CONTOURED ANTERIOR SPINAL FI...

K904446 is an FDA 510(k) clearance for CASF (TM) (CONTOURED ANTERIOR SPINAL FI..., manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K904446 · Acromed Corp. · Orthopedic device
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Sep 1991
Decision
342d
Days
Class 2
Risk

K904446 is an FDA 510(k) clearance for the CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.). Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Acromed Corp. devices

FDA 510(k) Submission Details - K904446

510(k) Number K904446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date September 05, 1991
Days to Decision 342 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
220d slower than avg
Panel avg: 122d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K904446.
AESCULAP TITANIUM BONE PLATES
K913730 · Aesculap, Inc. · Mar 1992
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)
K901507 · Kirschner Medical Corp. · Jan 1992
SIMMONS PLATING SYSTEM
K910681 · Smith & Nephew Richards, Inc. · Oct 1991
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · Acromed Corp. · Nov 1988
OEC/REZAIAN SPINAL FIXATOR
K841189 · Orthopedic Equipment Co., Inc. · May 1984
BRADFORD SPINAL FRACTURE FIXATION SYS
K831982 · Depuy, Inc. · Sep 1983