Cleared Traditional

K182477 - Cervical Spacer

K182477 is the FDA 510(k) clearance for Cervical Spacer by Additive Implants, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K182477 · Additive Implants, LLC · Orthopedic device
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Jan 2019
Decision
140d
Days
Class 2
Risk

K182477 is an FDA 510(k) clearance for the Cervical Spacer. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Additive Implants, LLC (Pheonix, US). The FDA issued a Cleared decision on January 28, 2019 after a review of 140 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.

View all Additive Implants, LLC devices

Submission Details

510(k) Number K182477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date January 28, 2019
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Backroads Consulting
Karen E. Warden

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 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K182477.
Shoreline Cervical Interbody RT System
K183083 · SeaSpine Orthopedics Corporation · Feb 2019
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
K183557 · Titan Spine, Inc. · Feb 2019
Velofix Interbody Fusion System
K190067 · U&I Corporation · Feb 2019
Tyber Medical PT Interbody Spacer
K182284 · Tyber Medical, LLC · Jan 2019
REVEL Spacers
K180909 · Globus Medical, Inc. · Dec 2018
Axis Chena Cervical PEEK Spacer System
K181140 · Axis Orthopaedics · Nov 2018