Cleared Traditional

Trabis (K173893) - FDA 510(k) Clearance

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

K173893 · Coligne AG · Orthopedic device
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Sep 2018
Decision
259d
Days
Class 2
Risk

K173893 is an FDA 510(k) clearance for the Trabis. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Coligne AG (Zurich, CH). The FDA issued a Cleared decision on September 6, 2018 after a review of 259 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 Coligne AG devices

Submission Details

510(k) Number K173893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date September 06, 2018
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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

The OrthoMedix Group, Inc.
J. D. Webb

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 K173893.
Normandy VBR System
K191423 · Zavation Medical Products, LLC · Aug 2019
VLIFT-s Vertebral Body Replacement System
K183071 · Stryker Spine · Jan 2019
NuVasive Monolith Cervical Corpectomy System
K180550 · Nu Vasive, Incorporated · Nov 2018
Normandy VBR System
K180673 · Zavation Medical Products, LLC · Jul 2018
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · Nu Vasive, Incorporated · Sep 2015