Cleared Traditional

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (K162358) - FDA 510(k) Clearance

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

K162358 · Synthes USA Products, LLC · Orthopedic device
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Nov 2016
Decision
70d
Days
Class 2
Risk

K162358 is an FDA 510(k) clearance for the T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (Raynham, US). The FDA issued a Cleared decision on November 1, 2016 after a review of 70 days - a notably fast clearance 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: 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K162358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date November 01, 2016
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 406
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K162358.
NuVasive CoRoent Ti-C System
K163707 · Nu Vasive, Incorporated · May 2017
NuVasive Modulus XLIF Interbody System
K163230 · Nu Vasive, Incorporated · Mar 2017
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer
K152022 · Globus Medical, Inc. · Feb 2017
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · Exactech, Inc. · May 2015
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
K130434 · Exactech, Inc. · May 2013