Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
FDA 510(k) K252822 · Atlas Spine, Inc.
510(k) numberK252822
Submission
- Device name
- Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- Applicant
- Atlas Spine, Inc.
Jupiter, FL, US - Received
- September 4, 2025
- Decision date
- July 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLR – Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Vertebral body replacement in the cervical spine.
Other 510(k)s with product code PLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | MiRus, LLC | 10/13/2023SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | K2m, Inc. | 02/24/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | Nexxt Spine, LLC | 02/24/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
| K191778 | Omnia Medical VBRPLR · Special | Omnia Medical, LLC | 08/28/2019SE |
More from Omnia Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | 11/10/2025SE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemMAX · Traditional | 08/15/2025SE |
| K243191 | Atlas Spine Lateral Expandable Interbody SystemOVD · Traditional | 11/26/2024SE |
| K202302 | Atlas Spine Rebar (Ti) Spacer SystemODP · Traditional | 10/30/2020SE |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemOVE · Traditional | 02/28/2020SE |
| K182418 | V3 Segmental Plating SystemKWQ · Traditional | 11/29/2018SE |
| K180675 | Atlas Spine Expandable Cervical Interbody SystemODP · Traditional | 06/13/2018SE |
| K172334 | Ortus Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 10/25/2017SE |
| K162918 | Atlas Spine Expandable Interbody SystemMAX · Traditional | 02/09/2017SE |
| K112759 | Apclo Pedicle Screw SystemsNKB · Special | 10/18/2011SE |
Questions and answers
When was Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant cleared by the FDA?
Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant (K252822) received a 510(k) decision of Substantially Equivalent on July 15, 2026, 314 days after the submission was received.
What is the product code of K252822?
The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.