Cleared Traditional

K170643 - Interbody Fusion (IBF)/Vertebral Body R...

K170643 is an FDA 510(k) clearance for Interbody Fusion (IBF)/Vertebral Body R..., manufactured by Rti Surgical, Inc. Dba Rti Biologics. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K170643 · Rti Surgical, Inc. Dba Rti Biologics · Orthopedic device
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Apr 2017
Decision
43d
Days
Class 2
Risk

K170643 is an FDA 510(k) clearance for the Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) 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 Rti Surgical, Inc. Dba Rti Biologics (Alachua, US). The FDA issued a Cleared decision on April 14, 2017 after a review of 43 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 Rti Surgical, Inc. Dba Rti Biologics devices

FDA 510(k) Submission Details - K170643

510(k) Number K170643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2017
Decision Date April 14, 2017
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 660
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170643.
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