Cleared Traditional

K082833 - NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER

K082833 is an FDA 510(k) clearance for NBX - NON-BRIDGING EXTERNAL FIXATOR - S..., manufactured by Nutek Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K082833 · Nutek Orthopaedics, Inc. · Orthopedic device
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Feb 2009
Decision
132d
Days
Class 2
Risk

K082833 is an FDA 510(k) clearance for the NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Nutek Orthopaedics, Inc. (Broward, US). The FDA issued a Cleared decision on February 5, 2009 after a review of 132 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 Nutek Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K082833

510(k) Number K082833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date February 05, 2009
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 K082833.
SMITH & NEPHEW RAIL SYSTEM
K090926 · Smith & Nephew, Inc. · Jun 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · DePuy Orthopaedics, Inc. · Mar 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · Sterilmed, Inc. · Mar 2009
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650 · Synthes (Usa) · Nov 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · Sterilmed, Inc. · Aug 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342 · Sterilmed, Inc. · Aug 2008