Cleared Traditional

K181921 - Solidity Vertebral Body Replacement

K181921 is an FDA 510(k) clearance for Solidity Vertebral Body Replacement, manufactured by Ulrich Medical USA. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K181921 · Ulrich Medical USA · Orthopedic device
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Nov 2018
Decision
121d
Days
Class 2
Risk

K181921 is an FDA 510(k) clearance for the Solidity Vertebral Body Replacement. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ulrich Medical USA (Chesterfield, US). The FDA issued a Cleared decision on November 16, 2018 after a review of 121 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 Ulrich Medical USA devices

FDA 510(k) Submission Details - K181921

510(k) Number K181921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2018
Decision Date November 16, 2018
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 189
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K181921.
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
FORTIFY Corpectomy Spacers
K173982 · Globus Medical, Inc. · Sep 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · Medtronic Sofamor Danek USA, Inc. · Sep 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
K173787 · Medos International SARL · Jun 2018