Cleared Traditional

K972568 - DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM

K972568 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 MNH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K972568 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
71d
Days
Class 2
Risk

K972568 is an FDA 510(k) clearance for the DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 19, 1997 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 K972568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date September 19, 1997
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K972568.
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · United States Surgical, A Division of Tyco Healthc · Mar 1998
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
K973425 · Corin USA · Feb 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213 · United States Surgical, A Division of Tyco Healthc · Feb 1998
AESUCLAP SOCON SPINAL SYSTEM
K970285 · Aesculap, Inc. · Jun 1997
EASY ROD
K970950 · Acromed Corp. · Jun 1997
ACROMED PEDICLE SCREW
K965102 · Acromed Corp. · May 1997