Cleared Traditional

K943378 - IMPLEX CEMENT RESTRICTOR SYSTEM

K943378 is an FDA 510(k) clearance for IMPLEX CEMENT RESTRICTOR SYSTEM, manufactured by Implex Corp.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K943378 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
72d
Days
Class 2
Risk

K943378 is an FDA 510(k) clearance for the IMPLEX CEMENT RESTRICTOR SYSTEM. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on September 23, 1994 after a review of 72 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 Implex Corp. devices

FDA 510(k) Submission Details - K943378

510(k) Number K943378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date September 23, 1994
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K943378.
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
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
K932595 · Johnson & Johnson Orthopaedics, Inc. · Sep 1994
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
UNIVERSAL BONE CEMENT KIT
K931540 · Biodynamic Technologies, Inc. · Jan 1994