# K202065: DOLOMITE Anterior Cervical Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical, LLC
- Decided: Oct 26, 2020 after 91 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: 19 generations back to K841189 (1984). 245 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160154: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2016) Summary page 4.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 4.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.

## Most influential descendants
- K242517: ProAM ACDF System (2024), 0 descendants of its own
- K223837: SPIRA®-C Integrated Fixation System (2023), 0 descendants of its own
- K210382: Blustone Synergy Diamond SA Cervical System (2021), 0 descendants of its own

## Indications for use
The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment prior to treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine. The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can’t be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine.

Source page: https://510kreport.com/device/K202065
Methodology: https://510kreport.com/methodology