Cleared Traditional

K952236 - ISOLA SYSTEM

K952236 is an FDA 510(k) clearance for ISOLA 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 255-day FDA review.

K952236 · Acromed Corp. · Orthopedic device
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Jan 1996
Decision
255d
Days
Class 2
Risk

K952236 is an FDA 510(k) clearance for the ISOLA 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 January 22, 1996 after a review of 255 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 - K952236

510(k) Number K952236 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 12, 1995
Decision Date January 22, 1996
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
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 K952236.
SPINE FIXATION
K943827 · Danek Medical, Inc. · Feb 1996
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · Sofamor Danek USA,Inc. · Feb 1996
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K950999 · Buckman Co., Inc. · Jan 1996
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635 · Sofamor Danek USA,Inc. · Oct 1995
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT
K950865 · Smith & Nephew Richards, Inc. · Sep 1995