Cleared Traditional

K190284 - Bengal Stackable Cage System

K190284 is the FDA 510(k) clearance for Bengal Stackable Cage System by Medos International SARL. It is a Class 2 Orthopedic device (product code PLR) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K190284 · Medos International SARL · Orthopedic device
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Dec 2019
Decision
312d
Days
Class 2
Risk

K190284 is an FDA 510(k) clearance for the Bengal Stackable Cage System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on December 20, 2019 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medos International SARL devices

Submission Details

510(k) Number K190284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date December 20, 2019
Days to Decision 312 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
190d slower than avg
Panel avg: 122d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Depuy Synthes Spine
Karin McDonough

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 - 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 K190284.
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
ALTA Anterior Cervical Corpectomy System
K190426 · Astura Medical, LLC · Oct 2019
Omnia Medical VBR
K191778 · Omnia Medical, LLC · Aug 2019
Normandy VBR System
K191423 · Zavation Medical Products, LLC · Aug 2019