Cleared Traditional

K150673 - SYNFIX Evolution Secured Spacer System

K150673 is the FDA 510(k) clearance for SYNFIX Evolution Secured Spacer System by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K150673 · Synthes USA Products, LLC · Orthopedic device
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Aug 2015
Decision
158d
Days
Class 2
Risk

K150673 is an FDA 510(k) clearance for the SYNFIX Evolution Secured Spacer System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (Raynham, US). The FDA issued a Cleared decision on August 21, 2015 after a review of 158 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.

View all Synthes USA Products, LLC devices

Submission Details

510(k) Number K150673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2015
Decision Date August 21, 2015
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K150673.
NuVasive® Interfixated Interbody System
K160051 · Nu Vasive, Incorporated · Apr 2016
Sahara Stabilization System
K151481 · K2m, Inc. · Dec 2015
NuVasive Foundation-LL System
K152943 · Nu Vasive, Incorporated · Dec 2015
ALIF Interfixated System
K151214 · Nu Vasive, Incorporated · Jun 2015
Chesapeake Stabilization System
K142487 · K2m, Inc. · May 2015
MAGNIFY and MAGNIFY-S Spacers
K142498 · Globus Medical, Inc. · Feb 2015