# K201073: Seaspine WaveForm C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Sep 18, 2020 after 149 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). 298 ancestors in all.
17 later devices descend from it; 2 cite it directly.
1 of 316 devices in its family (counting itself) has 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.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 4.
- K183083: Shoreline Cervical Interbody RT System, SeaSpine Orthopedics Corporation (2019) Summary page 4.

## Most influential descendants
- K212904: SeaSpine WaveForm C Interbody System (2021), 15 descendants of its own
- K233414: Shoreline ACS Interbody System; Shoreline RT Interbody System (2023), 8 descendants of its own
- K213359: SeaSpine WaveForm, C Interbody System (2021), 7 descendants of its own
- K223190: Hive™ Standalone Cervical System (2022), 5 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own

## Indications for use
The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used as a standalone system, the WaveForm™ C Interbody System, including the Low Profile and No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1), and must be used with bone screw fixation and locking covers. When used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C2-T1).

Source page: https://510kreport.com/device/K201073
Methodology: https://510kreport.com/methodology