Cleared Traditional

WRISTORE FIXATOR (K012294) - FDA 510(k) Clearance

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

K012294 · Millennium Medical Technologies, Inc. · Orthopedic device
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Mar 2002
Decision
227d
Days
Class 2
Risk

K012294 is an FDA 510(k) clearance for the WRISTORE FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Millennium Medical Technologies, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 227 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 Millennium Medical Technologies, Inc. devices

Submission Details

510(k) Number K012294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date March 04, 2002
Days to Decision 227 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 122d · This submission: 227d
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 K012294.
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · Synthes (Usa) · Jan 2003
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · DePuy Orthopaedics, Inc. · Aug 2002
OMEGA II SYSTEM
K020772 · Howmedica Osteonics Corp. · Jun 2002
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · DePuy Orthopaedics, Inc. · Nov 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · Synthes (Usa) · Jun 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · Synthes (Usa) · Jun 2001