Cleared Traditional

MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS (K951846) - FDA 510(k) Clearance

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

K951846 · Alphatec Mfg., Inc. · Orthopedic device
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Feb 1996
Decision
300d
Days
Class 2
Risk

K951846 is an FDA 510(k) clearance for the MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Concord, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Alphatec Mfg., Inc. devices

Submission Details

510(k) Number K951846 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 20, 1995
Decision Date February 14, 1996
Days to Decision 300 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 122d · This submission: 300d
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 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K951846.
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · Depuy, Inc. · Mar 1997
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · Osteonics Corp. · Dec 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · Depuy, Inc. · Feb 1996
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · Synthes (Usa) · Apr 1994