Cleared Traditional

K161649 - Virtu C Spinal Implant System

K161649 is an FDA 510(k) clearance for Virtu C Spinal Implant System, manufactured by Met 1 Technologies, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K161649 · Met 1 Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
147d
Days
Class 2
Risk

K161649 is an FDA 510(k) clearance for the Virtu C Spinal Implant System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Met 1 Technologies, LLC (El Paso, US). The FDA issued a Cleared decision on November 9, 2016 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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.

FDA 510(k) Submission Details - K161649

510(k) Number K161649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2016
Decision Date November 09, 2016
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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

Empirical Testing Corp
Kenneth C. Maxwell

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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K161649.
OIC Cervical PEEK Spacer
K160222 · The Orthopaedic Implant Company · Dec 2016
ShurFit CpTi-HA ACIF Interbody Fusion System
K161809 · Precision Spine, Inc. · Dec 2016
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
K162220 · Dio Medical Co., Ltd. · Nov 2016
NuVasive CoRoent Small Ti-C System
K162138 · Nu Vasive, Incorporated · Oct 2016
CAVUX™ Cervical Cage
K161642 · Providence Medical Technology, Inc. · Oct 2016
InterForm Cervical Interbody Cage System
K161608 · Next Orthosurgical · Sep 2016