Cleared Traditional

K980485 - ISOLA SPINAL SYSTEM

K980485 is an FDA 510(k) clearance for ISOLA SPINAL SYSTEM, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K980485 · Acromed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
254d
Days
Class 2
Risk

K980485 is an FDA 510(k) clearance for the ISOLA SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on October 21, 1998 after a review of 254 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 - K980485

510(k) Number K980485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date October 21, 1998
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K980485.
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · Depuy, Inc. · Dec 1998
CD SPINAL SYSTEM
K980184 · Sofamor Danek USA,Inc. · Dec 1998
DYNA-LOK SPINAL SYSTEM
K983672 · Sofamor Danek USA,Inc. · Dec 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987 · Synthes Spine · Oct 1998
TSRH SPINAL SYSTEM
K982990 · Sofamor Danek USA,Inc. · Oct 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · Spinal Concepts, Inc. · Oct 1998