Cleared Traditional

K032685 - CEMSTOP CEMENT RESTRICTOR

K032685 is an FDA 510(k) clearance for CEMSTOP CEMENT RESTRICTOR, manufactured by Teknimed, S.A.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K032685 · Teknimed, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
89d
Days
Class 2
Risk

K032685 is an FDA 510(k) clearance for the CEMSTOP CEMENT RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teknimed, S.A. devices

FDA 510(k) Submission Details - K032685

510(k) Number K032685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2003
Decision Date November 26, 2003
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 23
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K032685.
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
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · Kensey Nash Corp. · Sep 2001
CEMSTOP CEMENT RESTRICTOR
K993841 · Encore Orthopedics, Inc. · May 2000
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · Howmedica Osteonics Corp. · Aug 1999