Cleared Traditional

K073347 - DYNESYS TOP-LOADING SPINAL SYSTEM

K073347 is the FDA 510(k) clearance for DYNESYS TOP-LOADING SPINAL SYSTEM by Zimmer Spine, Inc.. It is a Class 2 Orthopedic device (product code NQP) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - NQP Posterior Metal/polymer Spinal System, Fusion

All 11
Devices cleared under the same product code (NQP) and FDA review panel - the closest regulatory comparables to K073347.
ZIMMER DTO PIN PRESS INSTRUMENT
K101704 · Zimmer Spine, Inc. · Aug 2010
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234 · Zimmer Spine, Inc. · Oct 2009
TRANSITION STABILIZATION SYSTEM
K073439 · Globus Medical, Inc. · Feb 2009
ZIMMER DTO IMPLANT
K071879 · Zimmer Spine, Inc. · Oct 2007
CD HORIZON SPINAL SYSTEM
K061304 · Medtronic Sofamor Danek · Jul 2006
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
K060638 · Zimmer Spine, Inc. · Apr 2006