Cleared Traditional

K982914 - AESCULAP SPINE SYSTEM EVOLUTION: ADDITI...

K982914 is an FDA 510(k) clearance for AESCULAP SPINE SYSTEM EVOLUTION: ADDITI..., manufactured by Aesculap, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K982914 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
44d
Days
Class 2
Risk

K982914 is an FDA 510(k) clearance for the AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS. 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 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K982914

510(k) Number K982914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1998
Decision Date October 02, 1998
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 K982914.
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · Spinal Concepts, Inc. · Oct 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
K983260 · Spinal Concepts, Inc. · Oct 1998
AESCULAP SPINE SYSTEM EVOLUTION
K980484 · Aesculap, Inc. · Oct 1998
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982686 · Sofamor Danek USA,Inc. · Aug 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982154 · Danek Medical, Inc. · Jul 1998
TOWNLEY PEDICLE SCREW PLATING SYSTEM
K970599 · Danek Medical, Inc. · Mar 1998