Cleared Traditional

K181231 - DePuy Synthes T-PAL Spacer System

K181231 is the FDA 510(k) clearance for DePuy Synthes T-PAL Spacer System by Depuy Synthes Spine. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K181231 · Depuy Synthes Spine · Orthopedic device
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Dec 2018
Decision
211d
Days
Class 2
Risk

K181231 is an FDA 510(k) clearance for the DePuy Synthes T-PAL Spacer 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 Depuy Synthes Spine (Raynham, US). The FDA issued a Cleared decision on December 6, 2018 after a review of 211 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 Depuy Synthes Spine devices

Submission Details

510(k) Number K181231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2018
Decision Date December 06, 2018
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 Consultant

DePuy Synthes
Rozanne Shirley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181231.
ROCCIA® PLIF
K181899 · Silony Medical GmbH · Dec 2018
Life Spine Resolute™ Threaded Cage System
K181625 · Life Spine, Inc. · Dec 2018
Lucent® XP
K182584 · Spinal Elements, Inc. · Dec 2018
PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
K181357 · Globus Medical, Inc. · Dec 2018
MectaLIF Posterior Extension
K181970 · Medacta International S.A. · Dec 2018
ATEC ALIF and LLIF Spacer System
K182746 · Alphatec Spine, Inc. · Nov 2018