Cleared Traditional

K183197 - PYRAMESH™ Implant System

K183197 is an FDA 510(k) clearance for PYRAMESH Implant System, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K183197 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
136d
Days
Class 2
Risk

K183197 is an FDA 510(k) clearance for the PYRAMESH™ Implant System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 4, 2019 after a review of 136 days - within the typical 510(k) review window.

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 Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K183197

510(k) Number K183197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date April 04, 2019
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 251
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K183197.
CarboClear VBR System
K192214 · CarboFix Orthopedics , Ltd. · Oct 2019
SYNMESH System
K183054 · Depuy Synthes Spine · May 2019
COLOSSEUM Mesh
K190147 · Globus Medical, Inc. · May 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588 · Choicespine · Feb 2019
T2 STRATOSPHERE Expandable Corpectomy System
K183510 · Medtronic Sofamor Danek USA, Inc. · Jan 2019
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K180665 · K2m, LLC · Nov 2018