# K242517: ProAM ACDF System

- Pathway: 510(k) (Traditional)
- Applicant: Pro Surgical, Inc.
- Decided: Nov 20, 2024 after 89 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: 33 generations back to K841189 (1984). 1,462 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,463 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202065: DOLOMITE Anterior Cervical Stabilization System, Astura Medical, LLC (2020) Summary page 5.
- K233414: Shoreline ACS Interbody System; Shoreline RT Interbody System, SeaSpine Orthopedics Corporation (2023) Summary page 5.
- K240126: ProAM ALIF System, Pro Surgical, Inc. (2024) Summary page 5.
- K151939: COALITION Spacers, Globus Medical, Inc. (2016) Summary page 5.

## Indications for use
The ProAM ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant. The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K242517
Methodology: https://510kreport.com/methodology