Cleared Traditional

AESCULAP SPINE SYSTEM EVOLUTION (K980484) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980484 · Aesculap, Inc. · Orthopedic device
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Oct 1998
Decision
235d
Days
Class 2
Risk

K980484 is an FDA 510(k) clearance for the AESCULAP SPINE SYSTEM EVOLUTION. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on October 2, 1998 after a review of 235 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 Aesculap, Inc. devices

Submission Details

510(k) Number K980484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date October 02, 1998
Days to Decision 235 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
113d slower than avg
Panel avg: 122d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K980484.
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · Osteonics Corp. · Feb 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · Howmedica Osteonics Corp. · Jan 1999
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · Depuy, Inc. · Dec 1998
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
K982914 · Aesculap, Inc. · Oct 1998