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FDA 510(k)

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

K-Number: K192718 · 2019-12-20

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Decision Date2019-12-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is a medical device manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval number K192718. 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 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K192718.

When was Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology approved by the FDA?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology received FDA 510(k) clearance on 2019-12-20, under approval number K192718.

What company makes Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc..

What is the FDA product code for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

The FDA product code for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT06604884 NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06291818 Self-Adhering Magnetic Device to Treat Corneal Exposure RECRUITING

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) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

Other Devices by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K161876Tritium® Sternal Cable Plate System K152793Unison-C Anterior Cervical Fixation System K170830Unison-C Anterior Cervical Fixation System K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System K200095Streamline Navigated Instruments

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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