Cleared Traditional

K951930 - CEMENTRALIZER DISTAL STEM CENTRALIZER

K951930 is an FDA 510(k) clearance for CEMENTRALIZER DISTAL STEM CENTRALIZER, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K951930 · Depuy, Inc. · Orthopedic device
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Jul 1995
Decision
97d
Days
Class 2
Risk

K951930 is an FDA 510(k) clearance for the CEMENTRALIZER DISTAL STEM CENTRALIZER. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K951930

510(k) Number K951930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1995
Decision Date July 11, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
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 25
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K951930.
ORTHOPLUG HARD BONE DESIGN
K955631 · Sunmed, Inc. · Feb 1996
ORTHOPLUG SOFT BONE DESIGN
K955632 · Sunmed, Inc. · Feb 1996
PRIME FEMORAL CEMENT PLUG
K955751 · Orthopaedic Innovations, Inc. · Jan 1996
EXETER INTRAMEDULLARY BONE PLUG
K933077 · Howmedica Corp. · May 1995
HOWMEDICE BONE PLUG
K951860 · Howmedica Corp. · May 1995
PFC CEMENT RESTRICTOR
K951934 · Johnson & Johnson Professionals, Inc. · May 1995