# K250764: SpineLinc Anterior Cervical Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Lincotek Medical
- Decided: Dec 5, 2025 after 267 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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). 245 ancestors in all.
No later device cites it as a predicate yet.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K142218: Coalition AGX Plate and Coalition AGX Spacer, Globus Medical, Inc. (2015) Summary page 6.
- K190885: Elevation Spine Saber-C System, Elevation Spine (2019) Summary page 6.

## Indications for use
The SPINELINC Anterior Cervical Implants include cervical 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 levels. 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. The SPINELINC Cervical Spacer Body and Anterior Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with three SpinelLinc screws per assembly.

Source page: https://510kreport.com/device/K250764
Methodology: https://510kreport.com/methodology