Cleared Traditional

K002923 - DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM

K002923 is an FDA 510(k) clearance for DYNAMIC JOINT DISTRACTOR II EXTERNAL FI..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002923 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2000
Decision
90d
Days
Class 2
Risk

K002923 is an FDA 510(k) clearance for the DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 18, 2000 after a review of 90 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K002923

510(k) Number K002923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2000
Decision Date December 18, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXT Device Classification - Class 2, Special Controls

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 49
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K002923.
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · Ebi, L.P. · Dec 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · Howmedica Osteonics Corp. · Jul 2001
BIOMET EXTERNAL WRIST PLATE
K003240 · Biomet, Inc. · Dec 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211 · Howmedica Osteonics Corp. · Dec 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760 · Biomet, Inc. · Aug 2000
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793 · Synthes (Usa) · Aug 2000