Cleared Traditional

K873826 - ACROMED/KANEDA ANTERIOR SPINAL INSTRUME...

K873826 is an FDA 510(k) clearance for ACROMED/KANEDA ANTERIOR SPINAL INSTRUME..., 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 434-day FDA review.

K873826 · Acromed Corp. · Orthopedic device
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Nov 1988
Decision
434d
Days
Class 2
Risk

K873826 is an FDA 510(k) clearance for the ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Acromed Corp. (Martinez, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 434 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: 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 Acromed Corp. devices

FDA 510(k) Submission Details - K873826

510(k) Number K873826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1987
Decision Date November 30, 1988
Days to Decision 434 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
312d slower than avg
Panel avg: 122d · This submission: 434d
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 K873826.
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)
K901507 · Kirschner Medical Corp. · Jan 1992
SIMMONS PLATING SYSTEM
K910681 · Smith & Nephew Richards, Inc. · Oct 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · Acromed Corp. · Sep 1991
OEC/REZAIAN SPINAL FIXATOR
K841189 · Orthopedic Equipment Co., Inc. · May 1984
BRADFORD SPINAL FRACTURE FIXATION SYS
K831982 · Depuy, Inc. · Sep 1983
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · Zimmer, Inc. · Oct 1980