Cleared Traditional

K911394 - ISOLA(TM) SPINE SYSTEM--EYE ROD

K911394 is an FDA 510(k) clearance for ISOLA(TM) SPINE SYSTEM--EYE ROD, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K911394 · Acromed Corp. · Orthopedic device
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Jun 1991
Decision
84d
Days
Class 2
Risk

K911394 is an FDA 510(k) clearance for the ISOLA(TM) SPINE SYSTEM--EYE ROD. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Acromed Corp. devices

FDA 510(k) Submission Details - K911394

510(k) Number K911394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date June 21, 1991
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K911394.
DANEK SACRAL HOOK, MODIFICATION
K911379 · Danek Medical, Inc. · Sep 1991
TSRH OPEN HEAD BONE SCREW
K911319 · Danek Medical, Inc. · Sep 1991
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
K911528 · Acromed Corp. · Jun 1991
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR
K905826 · Acromed Corp. · Mar 1991
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
K905184 · Acromed Corp. · Feb 1991
ACROMED SACRAL SCREW
K903376 · Acromed Corp. · Dec 1990