Cleared Traditional

K190284 - Bengal Stackable Cage System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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.