Cleared Traditional

K163481 - HALF DOME Posterior Lumbar Interbody System

K163481 is an FDA 510(k) clearance for HALF DOME Posterior Lumbar Interbody System, manufactured by Astura Medical. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K163481 · Astura Medical · Orthopedic device
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May 2017
Decision
142d
Days
Class 2
Risk

K163481 is an FDA 510(k) clearance for the HALF DOME Posterior 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 Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on May 3, 2017 after a review of 142 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 Astura Medical devices

FDA 510(k) Submission Details - K163481

510(k) Number K163481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date May 03, 2017
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 652
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K163481.
FUSE Spinal System
K171468 · Medtronic Sofamor Danek · Jun 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · Medtronic Sofamor Danek USA, Inc. · May 2017
MOJAVE Expandable Interbody System
K171097 · K2m, Inc. · May 2017
NuVasive CoRoent Ti-C System
K163707 · Nu Vasive, Incorporated · May 2017
Leva Anterior Expandable Spacer System
K163246 · Spine Wave, Inc. · Apr 2017
LOSPA IS TLIF & DLIF Cages
K170243 · Corentec Co., Ltd. · Mar 2017