Cleared Traditional

K993841 - CEMSTOP CEMENT RESTRICTOR

K993841 is an FDA 510(k) clearance for CEMSTOP CEMENT RESTRICTOR, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K993841 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
174d
Days
Class 2
Risk

K993841 is an FDA 510(k) clearance for the CEMSTOP CEMENT RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on May 4, 2000 after a review of 174 days - an extended review cycle.

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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K993841

510(k) Number K993841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date May 04, 2000
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
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 18
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K993841.
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
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