Cleared Traditional

K782123 - MULTIPLICITY OF PRODUCTS

K782123 is the FDA 510(k) clearance for MULTIPLICITY OF PRODUCTS by Depuy, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K782123 · Depuy, Inc. · Orthopedic device
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Jan 1979
Decision
14d
Days
Class 2
Risk

K782123 is an FDA 510(k) clearance for the MULTIPLICITY OF PRODUCTS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1979 after a review of 14 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 Depuy, Inc. devices

Submission Details

510(k) Number K782123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 10, 1979
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 942
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K782123.
CURVED SHERMAN BONE PLATE
K810061 · Howmedica Corp. · Jan 1981
POLYETHYLENE FILLED BONE PLATE
K801603 · Zimmer, Inc. · Oct 1980
I.C.S. MINI & SMALL FRAGMENT SET
K800806 · Howmedica Corp. · Apr 1980
B.G. COMPRESSION SYSTEM
K770128 · Howmedica Corp. · Jan 1977
GALLENAUGH BONE PLATES
K761150 · Orthopedic Equipment Co., Inc. · Dec 1976