Cleared Traditional

K171489 - Acapella Cervical Spacer System (FDA 510(k) Clearance)

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

K171489 · Choicespine, LP · Orthopedic device
Oct 2017
Decision
154d
Days
Class 2
Risk

K171489 is an FDA 510(k) clearance for the Acapella Cervical Spacer System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on October 23, 2017 after a review of 154 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.

Submission Details

510(k) Number K171489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date October 23, 2017
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 116d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 22
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K171489.
E3D™-C Interbody System
K260038 · Evolution Spine · Feb 2026
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · Globus Medical, Inc. · Dec 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · 4Web Medical, Inc. · Dec 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · Innovasis · Sep 2025
SABER-C System
K250540 · Elevation Spine · Aug 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · Acuity Surgical Devices, LLC · Jul 2025