Cleared Traditional

AUTOGENESIS(TM) AUTOMATOR (K905514) - FDA 510(k) Clearance

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

K905514 · Advanced Biosearch Assn. · Orthopedic device
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Apr 1991
Decision
116d
Days
Class 2
Risk

K905514 is an FDA 510(k) clearance for the AUTOGENESIS(TM) AUTOMATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Danville, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Advanced Biosearch Assn. devices

Submission Details

510(k) Number K905514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date April 02, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K905514.
MONOTUBE EXTERNAL FIXATION SYSTEM
K910483 · Howmedica Corp. · Jul 1992
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · Howmedica Corp. · Jan 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
ALTA LAG SCREW AND COMPRESSION SCREW
K900584 · Howmedica Corp. · Apr 1990
GAMMA LOCKING NAIL
K893639 · Howmedica Corp. · Aug 1989
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT
K873459 · Howmedica Corp. · Oct 1987