Cleared Traditional

K191791 - TranS1 Interbody Fusion System

K191791 is the FDA 510(k) clearance for TranS1 Interbody Fusion System by Trans1. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K191791 · Trans1 · Orthopedic device
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Sep 2019
Decision
84d
Days
Class 2
Risk

K191791 is an FDA 510(k) clearance for the TranS1 Interbody Fusion 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 Trans1 (Wilmington, US). The FDA issued a Cleared decision on September 25, 2019 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trans1 devices

Submission Details

510(k) Number K191791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date September 25, 2019
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K191791.
3d Cage
K180347 · Fims Co., Ltd. · Oct 2019
NuVasive Modulus XLIF Interbody System
K192760 · Nu Vasive, Incorporated · Oct 2019
DualX Lumbar Intervertebral Body Fusion Device
K192434 · Amplify Surgical, Inc. · Oct 2019
SPIRA Open Matrix ALIF and LLIF
K190483 · Camber Spine Technologies · Sep 2019
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
K190563 · Solco Biomedical Co., Ltd. · Sep 2019
HEDRON Lumbar Spacers
K191391 · Globus Medical, Inc. · Sep 2019