Cleared Traditional

K080070 - K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080070 · Grace Medical, Inc. · Ear, Nose, Throat device
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Apr 2008
Decision
98d
Days
Class 2
Risk

K080070 is an FDA 510(k) clearance for the K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on April 17, 2008 after a review of 98 days - within the typical 510(k) review window.

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: 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 Grace Medical, Inc. devices

Submission Details

510(k) Number K080070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2008
Decision Date April 17, 2008
Days to Decision 98 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 89d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 73
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K080070.
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025