Cleared Traditional

K161081 - SeaSpine Shoreline ACS - Anterior Cervi...

K161081 is the FDA 510(k) clearance for SeaSpine Shoreline ACS - Anterior Cervi... by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K161081 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
149d
Days
Class 2
Risk

K161081 is an FDA 510(k) clearance for the SeaSpine Shoreline ACS - Anterior Cervical Standalone System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on September 14, 2016 after a review of 149 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K161081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2016
Decision Date September 14, 2016
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 114
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K161081.
Spine Wave Anterior Cervical Spine System
K162760 · Spine Wave, Inc. · Feb 2017
Irix-C Cervical Integrated Fusion System
K162944 · X-Spine Systems, Inc. · Nov 2016
NuVasive® CoRoent® Small Interlock™ System
K161442 · Nu Vasive, Incorporated · Sep 2016
Pro-Link® Stand-Alone Cervical Spacer System
K160066 · Life Spine, Inc. · Sep 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
K153352 · Spinal Elements, Inc. · Aug 2016
Cervical Stand Alone System
K161280 · Orthofix, Inc. · Jun 2016