Cleared Traditional

PFC CEMENT RESTRICTOR (K951934) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951934 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
21d
Days
Class 2
Risk

K951934 is an FDA 510(k) clearance for the PFC CEMENT RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raritan, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 21 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K951934 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 25, 1995
Decision Date May 16, 1995
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 11
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K951934.
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · Depuy, Inc. · Jul 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · Howmedica Corp. · May 1995
HOWMEDICE BONE PLUG
K951860 · Howmedica Corp. · May 1995
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · Howmedica Corp. · Aug 1985