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510(k) K251969

Atlas Spine Project X Expandable Posterior Lumbar Interbody System by Atlas Spine, Inc. — Product Code MAX

K251969 is an FDA 510(k) premarket notification submitted by Atlas Spine, Inc. for the device "Atlas Spine Project X Expandable Posterior Lumbar Interbody System". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Atlas Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
June 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Atlas Spine, Inc.

  • K252822 — Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (July 15, 2026)
  • K252560 — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (November 10, 2025)
  • K243191 — Atlas Spine Lateral Expandable Interbody System (November 26, 2024)
  • K202302 — Atlas Spine Rebar (Ti) Spacer System (October 30, 2020)
  • K192570 — Atlas Spine Expandable Cervical Standalone Interbody System (February 28, 2020)
  • K182418 — V3 Segmental Plating System (November 29, 2018)
  • K180675 — Atlas Spine Expandable Cervical Interbody System (June 13, 2018)
  • K172334 — Ortus™ Expandable Lumbar Interbody Fusion System (October 25, 2017)
  • K162918 — Atlas Spine Expandable Interbody System (February 9, 2017)
  • K112759 — APCLO PEDICLE SCREW SYSTEMS (October 18, 2011)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources