Cleared Traditional

K011943 - IMPRO VISE ABSORBABLE CEMENT FLOW RESTR...

K011943 is an FDA 510(k) clearance for IMPRO VISE ABSORBABLE CEMENT FLOW RESTR..., manufactured by Kensey Nash Corp.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K011943

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
Combination Product No
PCCP Authorized No
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.

LZN Device Classification - Class 2, Special Controls

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 22
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
TORNIER CEMENT RESTRICTOR
K061824 · Tornier · Sep 2006
BIOBUCK CEMENT RESTRICTOR
K023680 · Smith & Nephew, Inc. · Nov 2002
CEMSTOP CEMENT RESTRICTOR
K993841 · Encore Orthopedics, Inc. · May 2000
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · Howmedica Osteonics Corp. · Aug 1999
LINK CEMENT PLUG
K972411 · Turnkey Intergration USA, Inc. · Aug 1997