Cleared Traditional

K882454 - LUHR MICRO SYSTEM

K882454 is the FDA 510(k) clearance for LUHR MICRO SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K882454 · Howmedica Corp. · Orthopedic device
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Aug 1988
Decision
66d
Days
Class 2
Risk

K882454 is an FDA 510(k) clearance for the LUHR MICRO SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 19, 1988 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K882454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date August 19, 1988
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K882454.
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES
K890641 · Acufex Microsurgical, Inc. · Feb 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
K885250 · Howmedica Corp. · Feb 1989
ORTHOMET BONE PLATES
K875086 · Orthomet, Inc. · Jan 1988
HOFFMANN LEG LENGTHENING PLATE SYSTEM
K870388 · Howmedica Corp. · Apr 1987
KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM
K864924 · Kirschner Medical Corp. · Mar 1987