# K153629: ArcadiusXP C Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: May 25, 2016 after 159 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: 11 generations back to K841189 (1984). 32 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130274: Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System, Elite Surgical Supplies (Pty), Ltd. (2013) Summary page 6.

## Most influential descendants
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own
- K241467: Stable-C Interbody System (2024), 2 descendants of its own
- K261279: DeltaNEC Interbody System (2026), 0 descendants of its own

## Indications for use
The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/Tl disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies) using autograft bone. Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.

Source page: https://510kreport.com/device/K153629
Methodology: https://510kreport.com/methodology