Cleared Traditional

K133784 - VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION

K133784 is an FDA 510(k) clearance for VISTA-S DEVICE, manufactured by Zimmer Trabecular Metal Technology. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K133784 · Zimmer Trabecular Metal Technology · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
207d
Days
Class 2
Risk

K133784 is an FDA 510(k) clearance for the VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Zimmer Trabecular Metal Technology (Parsippany, US). The FDA issued a Cleared decision on July 7, 2014 after a review of 207 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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.

FDA 510(k) Submission Details - K133784

510(k) Number K133784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2013
Decision Date July 07, 2014
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K133784.
COROENT SMALL INTERBODY SYSTEM
K140921 · Nu Vasive, Incorporated · Jul 2014
VELOXTM INTERBODY FUSION SYSTEM
K140864 · U&I Corp. · Jul 2014
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
K132732 · Medyssey USA, Inc. · Jul 2014
INFILL CERVICAL
K140066 · Pinnacle Spine Group, LLC · May 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
INTESS CERVICAL CAGE SYSTEM
K133815 · Kalitec Direct, LLC · Apr 2014