Cleared Traditional

K150521 - Interbody Fusion (IBF)/Vertebral Body R...

K150521 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 ODP cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K150521 · Rti Surgical, Inc. Dba Rti Biologics · Orthopedic device
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May 2015
Decision
74d
Days
Class 2
Risk

K150521 is an FDA 510(k) clearance for the Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Rti Surgical, Inc. Dba Rti Biologics (Alachua, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 74 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 - K150521

510(k) Number K150521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date May 15, 2015
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 252
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K150521.
NuVasive CoRoent Small Interbody System
K150362 · Nu Vasive, Incorporated · Jun 2015
Reliance Cervical IBF System
K142269 · Reliance Medical Systems, LLC · Jun 2015
Ascendant TM Cervical Spacer System
K150130 · Exactech, Inc. · May 2015
Mecta-C TiPEEK
K142744 · Medacta International · May 2015
LnK Cervical Interbody Fusion Cage System
K143360 · L & K Biomed Co., Ltd. · Apr 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · Globus Medical, Inc. · Mar 2015