Cleared Traditional

MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) (K953915) - FDA 510(k) Clearance

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

K953915 · Depuy, Inc. · Orthopedic device
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Feb 1996
Decision
178d
Days
Class 2
Risk

K953915 is an FDA 510(k) clearance for the MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE). 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 February 15, 1996 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K953915 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 21, 1995
Decision Date February 15, 1996
Days to Decision 178 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
56d slower than avg
Panel avg: 122d · This submission: 178d
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 38
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K953915.
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
K963357 · Synthes (Usa) · Jan 1997
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · Wrightmedicaltechnologyinc · Sep 1996
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626 · Synthes (Usa) · Aug 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · Synthes (Usa) · Aug 1995