Cleared Special

K151276 - DePuy Synthes T-PAL Ti Spacer

K151276 is the FDA 510(k) clearance for DePuy Synthes T-PAL Ti Spacer by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 36-day FDA review.

K151276 · Synthes USA Products, LLC · Orthopedic device
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Jun 2015
Decision
36d
Days
Class 2
Risk

K151276 is an FDA 510(k) clearance for the DePuy Synthes T-PAL Ti Spacer. 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 June 18, 2015 after a review of 36 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes USA Products, LLC devices

Submission Details

510(k) Number K151276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date June 18, 2015
Days to Decision 36 days
Submission Type Special
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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151276.
Rampart-T Interbody Fusion System
K151020 · Spineology, Inc. · Jul 2015
Leva Spacer System
K151581 · Spine Wave, Inc. · Jul 2015
Px PEEK IBF System
K150500 · Innovasis, Inc. · Jun 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
ELEVATE Spinal System
K142559 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Battalion Universal Spacer System
K143740 · Alphatec Spine, Inc. · May 2015