Cleared Traditional

K910135 - THE UNIVERSAL CEMENT PLUG(TM)

K910135 is an FDA 510(k) clearance for THE UNIVERSAL CEMENT PLUG(TM), manufactured by Biotron , Ltd.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 55-day FDA review.

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

FDA 510(k) Submission Details - K910135

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.

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 26
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K910135.
UNIVERSAL BONE CEMENT KIT
K931540 · Biodynamic Technologies, Inc. · Jan 1994
RESORABPLUG
K920118 · Sofamor Danek Mfg., Inc. · Feb 1993
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · Orthomet, Inc. · Nov 1992
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
SILASTIC INFLATABLE BONE PLUG H.P.
K853186 · Dow Corning Corp. Healthcare Industries Materials · Sep 1985
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · Howmedica Corp. · Aug 1985