Cleared Traditional

K212126 - MediExpand Cervical Expandable VBR System

K212126 is an FDA 510(k) clearance for MediExpand Cervical Expandable VBR System, manufactured by Cmf Medicon Surgical, Inc.. The device is a Class 2 Orthopedic device with product code PLR cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K212126 · Cmf Medicon Surgical, Inc. · Orthopedic device
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Apr 2022
Decision
271d
Days
Class 2
Risk

K212126 is an FDA 510(k) clearance for the MediExpand Cervical Expandable VBR System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Cmf Medicon Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 4, 2022 after a review of 271 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 Cmf Medicon Surgical, Inc. devices

FDA 510(k) Submission Details - K212126

510(k) Number K212126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2021
Decision Date April 04, 2022
Days to Decision 271 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
149d slower than avg
Panel avg: 122d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLR Device Classification - Class 2, Special Controls

Product Code PLR Spinal Vertebral Body Replacement Device - Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Vertebral Body Replacement In The Cervical Spine.
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 - PLR Spinal Vertebral Body Replacement Device - Cervical

All 15
Devices cleared under the same product code (PLR) and FDA review panel - the closest regulatory comparables to K212126.
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
K252560 · Atlas Spine, Inc. · Nov 2025
RIGEL™ 3DR Anterior Cervical Corpectomy System
K232481 · MiRus, LLC · Oct 2023
Galileo Vertebral Body Replacement Device
K221542 · Bright Spine · Jan 2023
CAPRI Corpectomy Cage System
K211320 · K2m, Inc. · Feb 2022
Galileo Vertebral Body Replacement Device
K192145 · Bright Spine · Apr 2020
NEXXT MATRIXX System
K193412 · Nexxt Spine, LLC · Feb 2020