Cleared Traditional

K060518 - PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K060518 is an FDA 510(k) clearance for PARTIAL OSSICULAR REPLACEMENT PROSTHESES, 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 121-day FDA review.

K060518 · Grace Medical, Inc. · Ear, Nose, Throat device
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Jun 2006
Decision
121d
Days
Class 2
Risk

K060518 is an FDA 510(k) clearance for the 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 June 28, 2006 after a review of 121 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

FDA 510(k) Submission Details - K060518

510(k) Number K060518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2006
Decision Date June 28, 2006
Days to Decision 121 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 90d · This submission: 121d
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 K060518.
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070 · Grace Medical, Inc. · Apr 2008
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
K063374 · Grace Medical, Inc. · Dec 2006
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
K061853 · Grace Medical, Inc. · Aug 2006
SMART OFFSET STAPES PISTON
K033554 · Gyrus Ent LLC · Nov 2003
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
K021479 · Heinz Kurz GmbH Medizintechnik · May 2002
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
K013573 · Heinz Kurz GmbH Medizintechnik · Nov 2001