Cleared Traditional

DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM (K974573) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974573 · Depuy, Inc. · Orthopedic device
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Feb 1998
Decision
72d
Days
Class 2
Risk

K974573 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 February 18, 1998 after a review of 72 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 K974573 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 08, 1997
Decision Date February 18, 1998
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 98
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K974573.
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121 · Aesculap, Inc. · Jun 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452 · Osteonics Corp. · May 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · Synthes (Usa) · Apr 1998
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · Depuy, Inc. · Mar 1997
MOSS MIAMI SPINAL SYSTEM
K962628 · Depuy, Inc. · Mar 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · Depuy, Inc. · Mar 1997