# K200087: F3D Cervical Stand-Alone Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Jun 15, 2020 after 152 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: 22 generations back to K841189 (1984). 406 ancestors in all.
25 later devices descend from it; 4 cite it directly.
1 of 432 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190546: NEXXT MATRIXX Stand Alone Cervical System, Nexxt Spine, LLC (2019) 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.
- K190655: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2019) Summary page 5.
- K152793: Unison-C Anterior Cervical Fixation System, Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (2016) Summary page 5.
- K171489: Acapella Cervical Spacer System, Choicespine, LP (2017) Summary page 5.

## Most influential descendants
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K223105: Tesera-K SC System (2022), 5 descendants of its own
- K223190: Hive™ Standalone Cervical System (2022), 5 descendants of its own
- K240838: Spectrum Spine Cervical Cage System (2024), 4 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 F3D 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D 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) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K200087
Methodology: https://510kreport.com/methodology