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510(k) K181014

Tritanium PL Cage by Stryker Spine — Product Code MAX

K181014 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "Tritanium PL Cage". The FDA issued a decision of Substantially Equivalent on July 18, 2018. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Stryker Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2018
Date Received
April 17, 2018
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 Stryker Spine

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioa (April 24, 2026)
  • K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal Sy (November 7, 2024)
  • K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioa (August 29, 2024)
  • K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serr (June 8, 2023)
  • K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Poste (February 14, 2023)
  • K203205 — Navigated Spine Instruments (March 23, 2021)
  • K200666 — Stryker Xia 3 Power Adaptor (April 23, 2020)
  • K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curve (July 25, 2019)
  • K183071 — VLIFT-s Vertebral Body Replacement System (January 10, 2019)

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