Cleared Traditional

K891066 - DANEK WRIST FIXATOR

K891066 is an FDA 510(k) clearance for DANEK WRIST FIXATOR, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K891066 · Danek Medical, Inc. · Orthopedic device
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Aug 1989
Decision
180d
Days
Class 2
Risk

K891066 is an FDA 510(k) clearance for the DANEK WRIST FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 180 days - an extended review cycle.

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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K891066

510(k) Number K891066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date August 28, 1989
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K891066.
ALTA LAG SCREW AND COMPRESSION SCREW
K900584 · Howmedica Corp. · Apr 1990
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
K890989 · Origin Medsystems, Inc. · Apr 1990
INTRAMEDULLARY HIP SCREW
K895241 · Richards Medical Co., Inc. · Jan 1990
GAMMA LOCKING NAIL
K893639 · Howmedica Corp. · Aug 1989
DANEK RING FIXATOR (DRF)
K890814 · Danek Medical, Inc. · Jun 1989
TECHMEDICA MP SYSTEM
K882922 · Techmedica, Inc. · Sep 1988