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FDA 510(k)

KMTI S141 Lumbar Interbody Fusion System

K-Number: K212070 · 2021-08-30

ApplicantKyocera Medical Technologies, Inc.
Decision Date2021-08-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMTI S141 Lumbar Interbody Fusion System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-30 under approval number K212070. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMTI S141 Lumbar Interbody Fusion System?

KMTI S141 Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2021-08-30. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K212070.

When was KMTI S141 Lumbar Interbody Fusion System approved by the FDA?

KMTI S141 Lumbar Interbody Fusion System received FDA 510(k) clearance on 2021-08-30, under approval number K212070.

What company makes KMTI S141 Lumbar Interbody Fusion System?

KMTI S141 Lumbar Interbody Fusion System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for KMTI S141 Lumbar Interbody Fusion System?

The FDA product code for KMTI S141 Lumbar Interbody Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Kyocera Medical Technologies, Inc.

K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K200709Kyocera Bipolar Hip System K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System K203472KMTI Hip Replacement System K223105Tesera-K SC System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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