Cleared Traditional

K190721 - LongBow Ti

K190721 is the FDA 510(k) clearance for LongBow Ti by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K190721 · Life Spine, Inc. · Orthopedic device
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Nov 2019
Decision
239d
Days
Class 2
Risk

K190721 is an FDA 510(k) clearance for the LongBow Ti. 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 Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on November 14, 2019 after a review of 239 days - an extended review 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: 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 Life Spine, Inc. devices

Submission Details

510(k) Number K190721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2019
Decision Date November 14, 2019
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K190721.
SeaSpine Beachside System
K192132 · SeaSpine Orthopedics Corporation · Dec 2019
Peridot Intervertebral body fusion System
K192026 · Gbs Commonwealth Co., Ltd. · Nov 2019
Cortina™ [MAX] Lumbar Cage System
K192248 · Neurostructures, Inc. · Nov 2019
XIHPOS™ ZFUZE™ Interbody Fusion System
K190544 · Difusion Technologies · Nov 2019
IB3D ALIF
K191134 · Medicrea International SA · Oct 2019
3d Cage
K180347 · Fims Co., Ltd. · Oct 2019