Cleared Traditional

IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (K011943) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011943 · Kensey Nash Corp. · Orthopedic device
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Sep 2001
Decision
90d
Days
Class 2
Risk

K011943 is an FDA 510(k) clearance for the IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Kensey Nash Corp. devices

Submission Details

510(k) Number K011943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date September 19, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZN Cement Obturator
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 Orthopedic devices follow this clearance model.

Regulatory Peers - LZN Cement Obturator

All 12
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K011943.
Artisan Bone Plug, Universal Cement Restrictor
K220838 · Howmedica Osteonics, Dba Stryker Orthopaedics · May 2022
BIOBUCK CEMENT RESTRICTOR
K023680 · Smith & Nephew, Inc. · Nov 2002
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · Howmedica Osteonics Corp. · Aug 1999
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · Osteonics Corp. · May 1997
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · Depuy, Inc. · Jul 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · Howmedica Corp. · May 1995