Cleared Traditional

K252822 - Atlas Spine HiRISE Expandable Cervical-...

K252822 is the FDA 510(k) clearance for Atlas Spine HiRISE Expandable Cervical-... by Atlas Spine, Inc.. It is a Class 2 Orthopedic device (product code PLR) cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K252822 · Atlas Spine, Inc. · Orthopedic device
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Jul 2026
Decision
314d
Days
Class 2
Risk

K252822 is an FDA 510(k) clearance for the Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on July 15, 2026 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Atlas Spine, Inc. devices

Submission Details

510(k) Number K252822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2025
Decision Date July 15, 2026
Days to Decision 314 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 122d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLR Spinal Vertebral Body Replacement Device - Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Vertebral Body Replacement In The Cervical Spine.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PLR Spinal Vertebral Body Replacement Device - Cervical

All 16
Devices cleared under the same product code (PLR) and FDA review panel - the closest regulatory comparables to K252822.
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
K252560 · Atlas Spine, Inc. · Nov 2025
RIGEL™ 3DR Anterior Cervical Corpectomy System
K232481 · MiRus, LLC · Oct 2023
Galileo Vertebral Body Replacement Device
K221542 · Bright Spine · Jan 2023
MediExpand Cervical Expandable VBR System
K212126 · Cmf Medicon Surgical, Inc. · Apr 2022
CAPRI Corpectomy Cage System
K211320 · K2m, Inc. · Feb 2022
Galileo Vertebral Body Replacement Device
K192145 · Bright Spine · Apr 2020