Cleared Special

Ascential IBD PEEKc Spacer (K161407) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161407 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
56d
Days
Class 2
Risk

K161407 is an FDA 510(k) clearance for the Ascential IBD PEEKc Spacer. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on July 15, 2016 after a review of 56 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Spine devices

Submission Details

510(k) Number K161407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2016
Decision Date July 15, 2016
Days to Decision 56 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 168
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K161407.
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
K172587 · Medacta International S.A. · Sep 2017
Tritanium C Anterior Cervical Cage
K171496 · Stryker Spine · Sep 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
Ascendant TM Cervical Spacer System
K150130 · Exactech, Inc. · May 2015
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc. · Jun 2011