# K252822: Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, Inc.
- Decided: Jul 15, 2026 after 314 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K192570 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192570: Atlas Spine Expandable Cervical Standalone Interbody System, Atlas Spine, Inc. (2020)

## Cited in the summary but kept off the family tree
- K252560: Atlas Spine HiRISE™ Expandable Cervical Corpectomy System, Atlas Spine, Inc. (2025). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K180670: ICONN Campbell Interference Screw, Iconn Orthopedics, LLC (2018). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Atlas Spine HIRISE™ Expandable Cervical-p Corpectomy Implant is indicated for vertebral body replacement in the cervical spine (C2-T1). The implant is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the cervical spine (C2-T1), Atlas Spine HIRISE™ Expandable Cervical-p Corpectomy implants are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The implant is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine.

Source page: https://510kreport.com/device/K252822
Methodology: https://510kreport.com/methodology