Cleared Traditional

K920118 - RESORABPLUG

K920118 is an FDA 510(k) clearance for RESORABPLUG, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K920118 · Sofamor Danek Mfg., Inc. · Orthopedic device
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Feb 1993
Decision
392d
Days
Class 2
Risk

K920118 is an FDA 510(k) clearance for the RESORABPLUG. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on February 8, 1993 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K920118

510(k) Number K920118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date February 08, 1993
Days to Decision 392 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 122d · This submission: 392d
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 20
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K920118.
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · Implex Corp. · Sep 1994
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
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
SILASTIC INFLATABLE BONE PLUG H.P.
K853186 · Dow Corning Corp. Healthcare Industries Materials · Sep 1985