Cleared Traditional

THE UNIVERSAL CEMENT PLUG(TM) (K910135) - FDA 510(k) Clearance

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

K910135 · Biotron , Ltd. · Orthopedic device
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Mar 1991
Decision
55d
Days
Class 2
Risk

K910135 is an FDA 510(k) clearance for the THE UNIVERSAL CEMENT PLUG(TM). Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Biotron , Ltd. (Tequesta, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 55 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 Biotron , Ltd. devices

Submission Details

510(k) Number K910135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date March 05, 1991
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 122d · This submission: 55d
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 K910135.
HOWMEDICE BONE PLUG
K951860 · Howmedica Corp. · May 1995
PFC CEMENT RESTRICTOR
K951934 · Johnson & Johnson Professionals, Inc. · May 1995
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · Howmedica Corp. · Aug 1985
WROUGHT (FORGED) VITALLIUM
K771408 · Howmedica Corp. · Aug 1977