Cleared Traditional

K181591 - Fixated Asfora BULLET CAGE (FABC)

K181591 is the FDA 510(k) clearance for Fixated Asfora BULLET CAGE (FABC) by Medical Designs, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K181591 · Medical Designs, LLC · Orthopedic device
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Sep 2018
Decision
100d
Days
Class 2
Risk

K181591 is an FDA 510(k) clearance for the Fixated Asfora BULLET CAGE® (FABC). 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 Medical Designs, LLC (Sioux Falls, US). The FDA issued a Cleared decision on September 26, 2018 after a review of 100 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 Medical Designs, LLC devices

Submission Details

510(k) Number K181591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2018
Decision Date September 26, 2018
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181591.
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K181531 · Spineex, Inc. · Oct 2018
NuVasive Cohere Thoracolumbar Interbody System
K181860 · Nu Vasive, Incorporated · Oct 2018
DualX
K181397 · Innovasive, Inc. · Sep 2018
Tranquil-L Interbody System
K181702 · Nexus Spine, LLC · Sep 2018
Sypher Spacer System
K181337 · Biogennix, LLC · Sep 2018
LnK Lumbar Interbody Fusion Cage System
K181380 · L & K Biomed Co., Ltd. · Sep 2018