# K173324: ALTA Anterior Cervical Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Feb 27, 2018 after 130 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: 15 generations back to K841189 (1984). 83 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 111 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.
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device, Spinefrontier, Inc. (2014) Summary page 4.
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K182477: Cervical Spacer (2019), 15 descendants of its own
- K193359: SureMAX Family of Cervical Spacers (2020), 14 descendants of its own
- K202666: CONSTRUX Mini PTC Spacer System (2020), 10 descendants of its own
- K203342: CONSTRUX Mini Ti Spacer System (2021), 9 descendants of its own
- K202949: CONSTRUX Mini PEEK Spacer System (2020), 6 descendants of its own

## Indications for use
The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K173324
Methodology: https://510kreport.com/methodology