Cleared Traditional

K063374 - NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE

K063374 is an FDA 510(k) clearance for NITINOL LOCKING INCUDO-STAPEDIAL JOINT, 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 28-day FDA review.

K063374 · Grace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
28d
Days
Class 2
Risk

K063374 is an FDA 510(k) clearance for the NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTO.... 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 December 6, 2006 after a review of 28 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 - K063374

510(k) Number K063374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date December 06, 2006
Days to Decision 28 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
62d faster than avg
Panel avg: 90d · This submission: 28d
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 K063374.
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
K130512 · Heinz Kurz GmbH Medizintechnik · Dec 2013
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
K112616 · Heinz Kurz GmbH Medizintechnik · Feb 2013
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070 · Grace Medical, Inc. · Apr 2008
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
K061853 · Grace Medical, Inc. · Aug 2006
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K060518 · Grace Medical, Inc. · Jun 2006
SMART OFFSET STAPES PISTON
K033554 · Gyrus Ent LLC · Nov 2003