# K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Jun 15, 2017 after 108 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003155 (2001). 80 ancestors in all.
82 later devices descend from it; 4 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161081: SeaSpine Shoreline ACS - Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- K151939: COALITION Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene, SeaSpine Orthopedics Corporation (2016) Summary page 4.

## Most influential descendants
- K190655: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (2019), 74 descendants of its own
- K183083: Shoreline Cervical Interbody RT System (2019), 60 descendants of its own
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (2021), 39 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own

## Indications for use
The SeaSpine® Shoreline ACS is a stand-alone device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T1). The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The cervical device is to be used with bone screw fixation and a locking cover.

Source page: https://510kreport.com/device/K170569
Methodology: https://510kreport.com/methodology