Cleared Traditional

Align Cervical Interbody Fusion System (K230639) - FDA 510(k) Clearance

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

K230639 · Acuity Surgical Devices, LLC · Orthopedic device
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Dec 2023
Decision
268d
Days
Class 2
Risk

K230639 is an FDA 510(k) clearance for the Align Cervical Interbody Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Acuity Surgical Devices, LLC (Irving, US). The FDA issued a Cleared decision on December 1, 2023 after a review of 268 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.

View all Acuity Surgical Devices, LLC devices

Submission Details

510(k) Number K230639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2023
Decision Date December 01, 2023
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
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 K230639.
Tranquil-C Interbody System
K240416 · Nexus Spine, LLC · Mar 2024
BEE Cervical Cage
K231371 · NGMedical GmbH · Jan 2024
Peridot-PT Anterior Cervical Intervertebral body fusion System
K233839 · Gbs Commonwealth Co., Ltd. · Dec 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
K233084 · Gbs Commonwealth Co., Ltd. · Nov 2023
ClariVy™ Cervical IBF System
K231836 · Vy Spine, LLC · Oct 2023
Acro Composites Interbody System
K230478 · Acro Composites, LLC · Oct 2023