# K160154: ALTA Anterior Cervical Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: May 13, 2016 after 114 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: 13 generations back to K003155 (2001). 64 ancestors in all.
63 later devices descend from it; 5 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 4.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 4.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.

## Most influential descendants
- K163481: HALF DOME Posterior Lumbar Interbody System (2017), 31 descendants of its own
- K173324: ALTA Anterior Cervical Interbody Spacer (2018), 27 descendants of its own
- K182877: HALF DOME Posterior Lumbar Interbody System (2019), 21 descendants of its own
- K182477: Cervical Spacer (2019), 15 descendants of its own
- K192006: SIRION Lateral Lumbar Interbody System (2020), 14 descendants of its own

## Indications for use
The ALTA 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. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

Source page: https://510kreport.com/device/K160154
Methodology: https://510kreport.com/methodology