Cleared Traditional

K955348 - TITANIUM MOSS MIAMI SPINAL SYSTEM

K955348 is the FDA 510(k) clearance for TITANIUM 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 87-day FDA review.

K955348 · Depuy, Inc. · Orthopedic device
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Feb 1996
Decision
87d
Days
Class 2
Risk

K955348 is an FDA 510(k) clearance for the TITANIUM 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 16, 1996 after a review of 87 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 K955348 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 21, 1995
Decision Date February 16, 1996
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K955348.
COTREL-DUBOUSSET (CD) SPINAL
K955807 · Sofamor Danek USA,Inc. · Oct 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · Sofamor Danek USA,Inc. · Mar 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696 · Smith & Nephew Richards, Inc. · Mar 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164 · Sofamor Danek USA,Inc. · Feb 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · Sofamor Danek USA,Inc. · Jan 1996
STRYKER 2S SPINAL SYSTEM
K930009 · Stryker Corp. · Sep 1994