Cleared Traditional

K120991 - TRANS1 INTERBODY FUSION SYSTEM

K120991 is an FDA 510(k) clearance for TRANS1 INTERBODY FUSION SYSTEM, manufactured by Trans1 Incorporated. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K120991 · Trans1 Incorporated · Orthopedic device
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Aug 2012
Decision
143d
Days
Class 2
Risk

K120991 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 Incorporated (Wilmington, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 143 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 Trans1 Incorporated devices

FDA 510(k) Submission Details - K120991

510(k) Number K120991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date August 23, 2012
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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 682
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K120991.
CLYDESDALE SPINAL SYSTEM
K122591 · Medtronic Sofamor Danek, Inc. · Sep 2012
CAPSTONE SPINAL SYSTEM
K121760 · Medtronic Sofamor Danek USA, Inc. · Aug 2012
TETRIS II
K122317 · Signus Medizintechnik GmbH · Aug 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121096 · L & K Biomed Co., Ltd. · Jul 2012
DEPUY PULSE LUMBAR CAGE SYSTEM
K120966 · Medos International SARL · Jul 2012
NUVASIVE COROENT TITANIUM SYSTEM
K120918 · Nuvasive, Inc. · Jun 2012