Cleared Special

K981274 - ACROMED TIMX PLATE BASED LOW BACK SYSTEM

K981274 is an FDA 510(k) clearance for ACROMED TIMX PLATE BASED LOW BACK SYSTEM, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 21-day FDA review.

K981274 · Acromed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
21d
Days
Class 2
Risk

K981274 is an FDA 510(k) clearance for the ACROMED TIMX PLATE BASED LOW BACK SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on April 29, 1998 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acromed Corp. devices

FDA 510(k) Submission Details - K981274

510(k) Number K981274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date April 29, 1998
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K981274.
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714 · Acromed Corp. · Jun 1998
PEDIATRIC PRC
K981113 · Acromed Corp. · May 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · United States Surgical, A Division of Tyco Healthc · May 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · DePuy Orthopaedics, Inc. · Apr 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · Wrightmedicaltechnologyinc · Apr 1998
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687 · Spinal Concepts, Inc. · Mar 1998