# K201646: Shoreline ACS (Anterior Cervical System)

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Sep 14, 2020 after 89 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: 19 generations back to K841189 (1984). 261 ancestors in all.
20 later devices descend from it; 2 cite it directly.
1 of 282 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190655: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2019) Summary page 4.
- K183083: Shoreline Cervical Interbody RT System, SeaSpine Orthopedics Corporation (2019) Summary page 4.

## Most influential descendants
- K201193: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L  NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (2020), 18 descendants of its own
- K210583: SeaSpine WaveForm™ A Interbody System (2021), 14 descendants of its own
- K220711: SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (2022), 10 descendants of its own
- K222732: WaveForm A Interbody System (2022), 9 descendants of its own
- K233694: Meridian Interbody System; WaveForm A Interbody System (2024), 8 descendants of its own

## Indications for use
The Shoreline ACS (Anterior Cervical System) are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment. When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover. When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).

Source page: https://510kreport.com/device/K201646
Methodology: https://510kreport.com/methodology