Cleared Traditional

K884884 - OSSICULAR PROSTHESIS: 8 PARTIAL

K884884 is an FDA 510(k) clearance for OSSICULAR PROSTHESIS: 8 PARTIAL, manufactured by Porex Technologies Corp. of Georgia. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K884884 · Porex Technologies Corp. of Georgia · Ear, Nose, Throat device
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Jun 1989
Decision
206d
Days
Class 2
Risk

K884884 is an FDA 510(k) clearance for the OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Porex Technologies Corp. of Georgia (Fairburn, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 206 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - the FDA ear, nose and throat device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Porex Technologies Corp. of Georgia devices

FDA 510(k) Submission Details - K884884

510(k) Number K884884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date June 16, 1989
Days to Decision 206 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 89d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETA Replacement, Ossicular Prosthesis, Total

All 21
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K884884.
RICHARDS TORP
K952549 · Smith & Nephew Richards, Inc. · Jul 1995
HAPEX MALLEABLE TORP
K950927 · Smith & Nephew Richards, Inc. · Mar 1995
BLACK OVAL-TOP TORP/PORP
K934107 · Smith & Nephew Richards, Inc. · Jun 1994
SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
K864444 · Richards Medical Co., Inc. · Feb 1987
EGG-TOP TORP AND EGG-TOP PORP
K864443 · Richards Medical Co., Inc. · Feb 1987
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823912 · Treace Medical, Inc. · Jun 1983