Cleared Traditional

K180364 - HD LifeSciences Cervical IBFD System

K180364 is the FDA 510(k) clearance for HD LifeSciences Cervical IBFD System by Hd Lifesciences, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K180364 · Hd Lifesciences, LLC · Orthopedic device
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Jun 2018
Decision
135d
Days
Class 2
Risk

K180364 is an FDA 510(k) clearance for the HD LifeSciences Cervical IBFD System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Hd Lifesciences, LLC (Stoneham, US). The FDA issued a Cleared decision on June 27, 2018 after a review of 135 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 Hd Lifesciences, LLC devices

Submission Details

510(k) Number K180364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date June 27, 2018
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 215
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K180364.
CxHA PEEK Cervical IBF System
K181115 · Innovasis, Inc. · Jul 2018
Curiteva Cervical Interbody Fusion System
K181261 · Curiteva, LLC · Jul 2018
Tyber Medical PT Interbody Spacer System
K180590 · Tyber Medical, LLC · Jul 2018
MONET™ Anterior Cervical Interbody Fusion Cage System
K172788 · Ctl Medical Corporation · Jun 2018
EVOL® ha-C Cervical Interbody Fusion System
K180674 · Cutting Edge Spine, LLC · Jun 2018
TiWAVE-C™ Porous Titanium Cervical Cage
K180401 · Kalitec Direct, LLC · Jun 2018