Cleared Traditional

K852449 - HOWMEDICA HIP SYS DISTAL CENTRALIZING S...

K852449 is the FDA 510(k) clearance for HOWMEDICA HIP SYS DISTAL CENTRALIZING S... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LZN) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K852449 · Howmedica Corp. · Orthopedic device
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Aug 1985
Decision
63d
Days
Class 2
Risk

K852449 is an FDA 510(k) clearance for the HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 63 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 K852449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date August 12, 1985
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K852449.
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · Orthomet, Inc. · Nov 1992
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
PLUG-LOK CEMENT RESTIRCTOR
K791125 · Richard'S Medical Equip., Inc. · Jun 1979
WROUGHT (FORGED) VITALLIUM
K771408 · Howmedica Corp. · Aug 1977