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510(k) K201614

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System by Innovasis, Inc. — Product Code MAX

K201614 is an FDA 510(k) premarket notification submitted by Innovasis, Inc. for the device "TxTiHA IBF System, AxTiHA Stand-Alone ALIF System". The FDA issued a decision of Substantially Equivalent on July 15, 2020. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Innovasis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
June 15, 2020
Clearance Type
Special
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 Innovasis, Inc.

  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Exce (July 23, 2025)
  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)
  • K250182 — Innovasis Navigation Instruments (March 24, 2025)
  • K241276 — Vector™ Pedicle Screw System (May 20, 2024)
  • K231899 — HAtetracell™-C Titanium Cervical IBF System (October 17, 2023)
  • K223511 — Excella Navigation Instruments (May 2, 2023)
  • K223510 — Matrix HA Fusion Porous Cervical IBF System (December 12, 2022)
  • K220875 — HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (August 26, 2022)
  • K212967 — AxTiHA Stand-Alone ALIF System (October 15, 2021)

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