Cleared Traditional

K853186 - SILASTIC INFLATABLE BONE PLUG H.P.

K853186 is an FDA 510(k) clearance for SILASTIC INFLATABLE BONE PLUG H.P., manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K853186 · Dow Corning Corp. Healthcare Industries Materials · Orthopedic device
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Sep 1985
Decision
56d
Days
Class 2
Risk

K853186 is an FDA 510(k) clearance for the SILASTIC INFLATABLE BONE PLUG H.P.. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Hemlock, US). The FDA issued a Cleared decision on September 24, 1985 after a review of 56 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 Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K853186

510(k) Number K853186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date September 24, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K853186.
UNIVERSAL BONE CEMENT KIT
K931540 · Biodynamic Technologies, Inc. · Jan 1994
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · Orthomet, Inc. · Nov 1992
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · Howmedica Corp. · Aug 1985
PLUG-LOK CEMENT RESTIRCTOR
K791125 · Richard'S Medical Equip., Inc. · Jun 1979
WROUGHT (FORGED) VITALLIUM
K771408 · Howmedica Corp. · Aug 1977