Cleared Traditional

K944737 - ISOLA SPINE SYSTEM

K944737 is an FDA 510(k) clearance for ISOLA SPINE SYSTEM, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K944737 · Acromed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
269d
Days
Class 2
Risk

K944737 is an FDA 510(k) clearance for the ISOLA SPINE 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 June 22, 1995 after a review of 269 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 Acromed Corp. devices

FDA 510(k) Submission Details - K944737

510(k) Number K944737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date June 22, 1995
Days to Decision 269 days
Submission Type Traditional
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
147d slower than avg
Panel avg: 122d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K944737.
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074 · Wrightmedicaltechnologyinc · Aug 1995
ACROMED PEDICLE SCREW
K951116 · Acromed Corp. · Aug 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348 · Sofamor Danek USA,Inc. · Aug 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · Smith & Nephew, Inc. · Jun 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298 · Smith & Nephew Richards, Inc. · Jun 1995
ISOLA OPEN AND CLOSED SCREWS
K944756 · Acromed Corp. · May 1995