# K212904: SeaSpine WaveForm C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Dec 14, 2021 after 92 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: 26 generations back to K841189 (1984). 549 ancestors in all.
15 later devices descend from it; 6 cite it directly.
1 of 565 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201073: Seaspine WaveForm C Interbody System, SeaSpine Orthopedics Corporation (2020) Summary page 4.
- K161081: SeaSpine Shoreline ACS - Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- K172676: NuVasive® Modulus-C Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K192582: NuVasive CoRoent Small Interlock System, Nu Vasive, Incorporated (2019) Summary page 5.
- K172064: Ti-Diagon Oblique TLIF, Camber Spine Technologies (2017) Summary page 5.
- K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5.

## Most influential descendants
- K233414: Shoreline ACS Interbody System; Shoreline RT Interbody System (2023), 8 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
- K241466: Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System (2024), 3 descendants of its own
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own

## Indications for use
The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple 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, the 2,3,4-hole TruProfile spacers and plates, are intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The 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 the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is 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 multiple contiguous levels of the cervical spine (C2-T1).

Source page: https://510kreport.com/device/K212904
Methodology: https://510kreport.com/methodology