Cleared Traditional

K891066 - DANEK WRIST FIXATOR (FDA 510(k) Clearance)

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

K891066 · Danek Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 402
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K891066.
DYNEX® External Fixation Systems
K260900 · Vilex, LLC · Apr 2026
QuikFix External Fixator: Knee-Spanning Pack
K260112 · Stabiliz Orthopaedics, Inc. · Mar 2026
Excelsior System
K253291 · Blue Ocean Global · Jan 2026
Hoffmann LRF System
K253202 · Stryker GmbH · Dec 2025
Monkey Rings External Ring Fixation System
K253613 · Paragon 28, Inc. · Dec 2025
Medusa Orthopedics Boa External Fixation System
K252555 · Medusa Orthopedics, LLC · Nov 2025