# K211417: F3D-C2 Cervical Stand-Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Feb 4, 2022 after 273 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). 492 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 496 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200087: F3D Cervical Stand-Alone Interbody Fusion System, Corelink, LLC (2020) Summary page 5.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 5.
- K152793: Unison-C Anterior Cervical Fixation System, Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (2016) Summary page 5.
- K191489: Genesys Spine 3DP Cervical Interbody System, Genesys Spine (2020) Summary page 5.

## Most influential descendants
- K251735: Stabilis SA Cervical Stand-Alone System (Various PNs) (2025), 1 descendant of its own
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own
- K230329: F3D Interbody System (2023), 0 descendants of its own

## Indications for use
The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

Source page: https://510kreport.com/device/K211417
Methodology: https://510kreport.com/methodology