# K210470: C-CURVE Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Sep 3, 2021 after 198 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: 25 generations back to K841189 (1984). 427 ancestors in all.
No later device cites it as a predicate yet.
1 of 428 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device, Titan Spine, Inc. (2019) Summary page 4.
- K192570: Atlas Spine Expandable Cervical Standalone Interbody System, Atlas Spine, Inc. (2020) Summary page 4.
- K073285: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K153373: CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device, Medtronic Sofamor Danek (2016) Summary page 4.
- K132894: Optio-C Anterior Cervical System, Zimmer Spine, Inc. (2014) Summary page 4.

## Indications for use
The C-CURVE® Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used C-Curve screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

Source page: https://510kreport.com/device/K210470
Methodology: https://510kreport.com/methodology