Cleared Traditional

K942060 - P.F.C. CEMENT RESTRICTOR

K942060 is the FDA 510(k) clearance for P.F.C. CEMENT RESTRICTOR by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code LZN) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K942060 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
144d
Days
Class 2
Risk

K942060 is an FDA 510(k) clearance for the P.F.C. CEMENT RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 144 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K942060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date September 20, 1994
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
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 18
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K942060.
HOWMEDICE BONE PLUG
K951860 · Howmedica Corp. · May 1995
PFC CEMENT RESTRICTOR
K951934 · Johnson & Johnson Professionals, Inc. · May 1995
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · Implex Corp. · 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