Cleared Traditional

K073347 - DYNESYS TOP-LOADING SPINAL SYSTEM (FDA 510(k) Clearance)

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

K073347 · Zimmer Spine, Inc. · Orthopedic device
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Feb 2008
Decision
71d
Days
Class 2
Risk

K073347 is an FDA 510(k) clearance for the DYNESYS TOP-LOADING SPINAL SYSTEM. Classified as Posterior Metal/polymer Spinal System, Fusion (product code NQP), Class II - Special Controls.

Submitted by Zimmer Spine, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Zimmer Spine, Inc. devices

Submission Details

510(k) Number K073347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 29, 2007
Decision Date February 08, 2008
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQP Posterior Metal/polymer Spinal System, Fusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumbar, And Sacral Spine.
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.