Cleared Traditional

K170676 - HD Lumbar Interbody System

K170676 is an FDA 510(k) clearance for HD Lumbar Interbody System, manufactured by Hd Lifesciences, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K170676 · Hd Lifesciences, LLC · Orthopedic device
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Jul 2017
Decision
129d
Days
Class 2
Risk

K170676 is an FDA 510(k) clearance for the HD Lumbar Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Hd Lifesciences, LLC (Stoneham, US). The FDA issued a Cleared decision on July 13, 2017 after a review of 129 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

FDA 510(k) Submission Details - K170676

510(k) Number K170676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date July 13, 2017
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 659
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170676.
The TiBow Expandable Spacer System
K170919 · Life Spine, Inc. · Aug 2017
Rampart L Lumbar Interbody Fusion Device
K171724 · Spineology, Inc. · Jul 2017
CONCORDE LIFT
K171425 · Medos International SARL · Jul 2017
Genesys Spine Apache Interbody Fusion System
K171656 · Genesys Spine · Jul 2017
CRESCENT™ Spinal System
K171031 · Medtronic Sofamor Danek · Jul 2017
NuVasive® CoRoent® Thoracolumbar System
K170962 · Nu Vasive, Incorporated · Jun 2017