Cleared Traditional

K965145 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

K965145 is the FDA 510(k) clearance for DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM by Depuy, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K965145 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
80d
Days
Class 2
Risk

K965145 is an FDA 510(k) clearance for the DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 13, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 K965145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date March 13, 1997
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K965145.
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · Depuy, Inc. · Mar 1997
BACFIX SPINAL FIXATION SYSTEM
K964404 · Spinal Concepts, Inc. · Mar 1997
MOSS MIAMI SPINAL SYSTEM
K962628 · Depuy, Inc. · Mar 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · Sofamor Danek USA,Inc. · Feb 1997
FINN ROD TO ROD CONNECTOR
K960444 · Smith & Nephew Richards, Inc. · Jan 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · Sofamor Danek USA,Inc. · Jan 1997