Cleared Traditional

ORIO-Ti Intervertebral Body Fusion Cage System (K211935) - FDA 510(k) Clearance

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

K211935 · Spinecraft, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
100d
Days
Class 2
Risk

K211935 is an FDA 510(k) clearance for the ORIO-Ti Intervertebral Body Fusion Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spinecraft, LLC (Westmont, US). The FDA issued a Cleared decision on September 30, 2021 after a review of 100 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 Spinecraft, LLC devices

Submission Details

510(k) Number K211935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2021
Decision Date September 30, 2021
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 K211935.
FIX-C PEEK Anterior Cervical Interbody System
K212266 · Jeil Medical Corporation · Dec 2021
Vy Spine ClariVy Cervical IBF System
K212715 · Vy Spine, LLC · Dec 2021
CHENA-C Spacer System
K213115 · Kahtnu Surgical, Inc. · Dec 2021
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212792 · Medynus, Inc. · Sep 2021
EDEN Peek Cage
K201793 · Jmt Co., Ltd. · Sep 2021
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
K211704 · Orthofix, Inc. · Aug 2021