# K152622: Alta ACDF System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Jul 8, 2016 after 298 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: 16 generations back to K003155 (2001). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151064: Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System, Biomet Spine (2015) Summary page 4.
- K112388: Lanx Cervical SA, Lanx, Inc. (2011) Summary page 4.

## Indications for use
The Alta ACDF System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. 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 Alta ACDF System is to be filled with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

Source page: https://510kreport.com/device/K152622
Methodology: https://510kreport.com/methodology