Cleared Traditional

K012294 - WRISTORE FIXATOR

K012294 is an FDA 510(k) clearance for WRISTORE FIXATOR, manufactured by Millennium Medical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K012294 · Millennium Medical Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K012294

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.

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 313
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K012294.
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K021091 · Ebi, L.P. · May 2002
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K020403 · Ebi, L.P. · Mar 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K014276 · Ebi, L.P. · Mar 2002
SLIM GLIDING NAIL SYSTEM
K020240 · Plus Orthopedics · Feb 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141 · Ebi, L.P. · Feb 2002