Cleared Traditional

NITRO Interbody Fusion Cage System Family (K220513) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220513 · Ctl Medical Corporation · Orthopedic device
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Apr 2023
Decision
427d
Days
Class 2
Risk

K220513 is an FDA 510(k) clearance for the NITRO Interbody Fusion Cage System Family. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Ctl Medical Corporation (Addison, US). The FDA issued a Cleared decision on April 25, 2023 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Ctl Medical Corporation devices

Submission Details

510(k) Number K220513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date April 25, 2023
Days to Decision 427 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
305d slower than avg
Panel avg: 122d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K220513.
Ventana™ C Spinal System
K222833 · Spinal Elements, Inc. · May 2023
ClariVy™ Cervical IBF System
K230414 · Vy Spine, LLC · May 2023
INTEGRATE -C Interbody Fusion System
K222004 · Happe Spine · Apr 2023
NEST-C Interbody System
K220261 · Paonan Biotech Co., Ltd. · Apr 2023
UniVy™ OsteoVy™-Ti Cervical IBF System
K223513 · Vy Spine, LLC · Apr 2023
SQUALE
K230026 · Implanet, S.A. · Mar 2023