Cleared Traditional

K050965 - TRANS1 AXIALIF SYSTEM

K050965 is an FDA 510(k) clearance for TRANS1 AXIALIF SYSTEM, manufactured by Trans1 Incorporated. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K050965 · Trans1 Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
57d
Days
Class 2
Risk

K050965 is an FDA 510(k) clearance for the TRANS1 AXIALIF SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Trans1 Incorporated (Wilmington, US). The FDA issued a Cleared decision on June 14, 2005 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trans1 Incorporated devices

FDA 510(k) Submission Details - K050965

510(k) Number K050965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date June 14, 2005
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 500
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K050965.
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BASIS SPINAL SYSTEM
K051039 · Medtronic Sofamor Danek USA, Inc. · May 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · Blackstone Medical, Inc. · May 2005
ABC 2 SCREW
K050813 · Aesculap, Inc. · May 2005