Cleared Traditional

AME UNIVERSAL FIXATION SYSTEM (K931381) - FDA 510(k) Clearance

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

K931381 · American Medical Electronics, Inc. · Orthopedic device
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Feb 1995
Decision
685d
Days
Class 2
Risk

K931381 is an FDA 510(k) clearance for the AME UNIVERSAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by American Medical Electronics, Inc. (Richardson, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 685 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all American Medical Electronics, Inc. devices

Submission Details

510(k) Number K931381 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 18, 1993
Decision Date February 01, 1995
Days to Decision 685 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
563d slower than avg
Panel avg: 122d · This submission: 685d
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 100
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K931381.
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
STRYKER 2S SPINAL SYSTEM
K930009 · Stryker Corp. · Sep 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994