Cleared Traditional

K945027 - TROCHANTER MESH

K945027 is an FDA 510(k) clearance for TROCHANTER MESH, manufactured by Acu Med, Inc.. The device is a Class 2 General & Plastic Surgery device with product code EZX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K945027 · Acu Med, Inc. · General & Plastic Surgery device
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Feb 1995
Decision
111d
Days
Class 2
Risk

K945027 is an FDA 510(k) clearance for the TROCHANTER MESH. Classified as Mesh, Surgical, Metal (product code EZX), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K945027

510(k) Number K945027 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 13, 1994
Decision Date February 01, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZX Device Classification - Class 2, Special Controls

Product Code EZX Mesh, Surgical, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - EZX Mesh, Surgical, Metal

All 11
Devices cleared under the same product code (EZX) and FDA review panel - the closest regulatory comparables to K945027.
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · Implex Corp. · Feb 2003
NUVASIVE MESH
K020853 · Nuvasive, Inc. · Jun 2002
SYNTHES SYNMESH
K983766 · Synthes (Usa) · Dec 1998
MOTECH TITANIUM SURGICAL MESH
K900138 · Biedermann Motech GmbH · Mar 1990
TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM
K896369 · Techmedica, Inc. · Nov 1989
STUART TITANIUM SURGICAL MESH
K890601 · Stuart · Mar 1989
K945027 · TROCHANTER MESH
Download PDF Acu Med, Inc.