510(k) · Cleared
ClearedAtlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Spine, Inc. · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Jul 15, 2026 as substantially equivalent to K192570 (Atlas Spine, Inc., 2020) after a 314-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jul 15, 2026
- Review
- 314 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K192570 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK192570 Atlas Spine Expandable Cervical Standalone Interbody SystemAtlas Spine, Inc. · 2020
- This deviceK252822 Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | Atlas Spine, Inc. | 2020 | — |
| 0 (this device) | K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLR device
- #1 K232481 RIGEL™ 3DR Anterior Cervical Corpectomy Systemscore 13.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K252560 | FDA’s K252560 is Atlas Spine HiRISE™ Expandable Cervical Corpectomy System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2025 |
| Kept off the family tree | K180670 | FDA’s K180670 is ICONN Campbell Interference Screw Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2018 |
| * | K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K192570.
How does its category compare?
All PLR devicesPLR Spinal Vertebral Body Replacement Device - Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLR
69in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLR
No recall names PLR since 2007.
Adverse event reports per year · PLR
1in 2025
MAUDE reports naming product code PLR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 259 | 0 | 1 |
| 2019 | 5 | 69 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252822: Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252822
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026