Cleared Traditional

K972815 - PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

K972815 is an FDA 510(k) clearance for PARTIAL/TOTAL/POROUS POLYETHYLENE OSSIC..., manufactured by Grace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K972815 · Grace Medical, Inc. · Ear, Nose, Throat device
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Oct 1997
Decision
72d
Days
Class 2
Risk

K972815 is an FDA 510(k) clearance for the PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Grace Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - 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: 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 Grace Medical, Inc. devices

FDA 510(k) Submission Details - K972815

510(k) Number K972815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1997
Decision Date October 08, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 90d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETB Device Classification - Class 2, Special Controls

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
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 - ETB Prosthesis, Partial Ossicular Replacement

All 59
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K972815.
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · Exmoor Plastics , Ltd. · May 1998
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
K-PISTON WITH BAND HOOK /ANGULAR PISTON
K973356 · Heinz Kurz · Nov 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · Mednet Locator, Inc. · Sep 1997
CAUSSE PISTON
K972737 · Mednet Locator, Inc. · Sep 1997
BELL PROSTHESIS (PARTIAL)
K972492 · Heinz Kurz · Aug 1997