Cleared Traditional

K905184 - ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK

K905184 is an FDA 510(k) clearance for ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK, 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 88-day FDA review.

K905184 · Acromed Corp. · Orthopedic device
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Feb 1991
Decision
88d
Days
Class 2
Risk

K905184 is an FDA 510(k) clearance for the ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK. 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 February 15, 1991 after a review of 88 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 - K905184

510(k) Number K905184 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 19, 1990
Decision Date February 15, 1991
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K905184.
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
K911528 · Acromed Corp. · Jun 1991
ISOLA(TM) SPINE SYSTEM--EYE ROD
K911394 · Acromed Corp. · Jun 1991
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR
K905826 · Acromed Corp. · Mar 1991
ACROMED SACRAL SCREW
K903376 · Acromed Corp. · Dec 1990
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005 · Danek Medical, Inc. · Dec 1990
KNIGHT SACRAL SCREW
K902775 · Danek Medical, Inc. · Dec 1990