Cleared Traditional

K951860 - HOWMEDICE BONE PLUG

K951860 is the FDA 510(k) clearance for HOWMEDICE BONE PLUG by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LZN) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K951860 · Howmedica Corp. · Orthopedic device
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May 1995
Decision
25d
Days
Class 2
Risk

K951860 is an FDA 510(k) clearance for the HOWMEDICE BONE PLUG. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 25 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 Howmedica Corp. devices

Submission Details

510(k) Number K951860 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 21, 1995
Decision Date May 16, 1995
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 16
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K951860.
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · Osteonics Corp. · May 1997
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · Depuy, Inc. · Jul 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · Howmedica Corp. · May 1995
PFC CEMENT RESTRICTOR
K951934 · Johnson & Johnson Professionals, Inc. · May 1995
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · Implex Corp. · Sep 1994
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994