Cleared Traditional

K183054 - SYNMESH System

K183054 is an FDA 510(k) clearance for SYNMESH System, manufactured by Depuy Synthes Spine. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K183054 · Depuy Synthes Spine · Orthopedic device
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May 2019
Decision
202d
Days
Class 2
Risk

K183054 is an FDA 510(k) clearance for the SYNMESH System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Depuy Synthes Spine (Raynham, US). The FDA issued a Cleared decision on May 23, 2019 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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

FDA 510(k) Submission Details - K183054

510(k) Number K183054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date May 23, 2019
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 236
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K183054.
Small VBR™
K192117 · Ulrich GmbH & Co. KG · Nov 2019
MediExpand TL Expandable VBR System
K190349 · Cmf Medicon Surgical, Inc. · Oct 2019
CarboClear VBR System
K192214 · CarboFix Orthopedics , Ltd. · Oct 2019
COLOSSEUM Mesh
K190147 · Globus Medical, Inc. · May 2019
PYRAMESH™ Implant System
K183197 · Medtronic Sofamor Danek USA, Inc. · Apr 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588 · Choicespine · Feb 2019