Cleared Traditional

K974213 - AURORA TITANIUM SPINAL ROD SYSTEM

K974213 is the FDA 510(k) clearance for AURORA TITANIUM SPINAL ROD SYSTEM by United States Surgical, A Division of Tyco Healthc. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K974213 · United States Surgical, A Division of Tyco Healthc · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
86d
Days
Class 2
Risk

K974213 is an FDA 510(k) clearance for the AURORA TITANIUM SPINAL ROD SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 86 days - a notably fast clearance 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: 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K974213 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 10, 1997
Decision Date February 04, 1998
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 156
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K974213.
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687 · Spinal Concepts, Inc. · Mar 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · United States Surgical, A Division of Tyco Healthc · Mar 1998
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
K973425 · Corin USA · Feb 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · Depuy, Inc. · Sep 1997
EBI SPINELINK SYSTEM
K971970 · Electro-Biology, Inc. · Aug 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285 · Aesculap, Inc. · Jun 1997