Cleared Traditional

K883727 - BUCKET PROSTHESIS PORP

K883727 is an FDA 510(k) clearance for BUCKET PROSTHESIS PORP, manufactured by Treace 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 135-day FDA review.

K883727 · Treace Medical, Inc. · Ear, Nose, Throat device
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Jan 1989
Decision
135d
Days
Class 2
Risk

K883727 is an FDA 510(k) clearance for the BUCKET PROSTHESIS PORP. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 135 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 Treace Medical, Inc. devices

FDA 510(k) Submission Details - K883727

510(k) Number K883727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1988
Decision Date January 13, 1989
Days to Decision 135 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 89d · This submission: 135d
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 36
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K883727.
HAPES MALLEABLE INCUS STAPES
K950984 · Smith & Nephew Richards, Inc. · Mar 1995
INCUDOSTAPEDIAL JOINT
K925443 · Smith & Nephew Richards, Inc. · Mar 1993
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · Smith & Nephew Richards, Inc. · Dec 1991
XOMED PLATINUM WIRE TEFLON PISTION
K872112 · Xomed, Inc. · Jul 1987
PROSTHESIS WIRE
K870766 · Treace Medical, Inc. · Apr 1987
INCUS/STAPES PROSTHESIS
K861369 · Richards Medical Co., Inc. · Jul 1986