COMPANY
Globus Medical
Timeline
- FDA FDA 510(k) clearance: TRIVANCE Hip Stem — K254043, Aug 4, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) — K262251, Jul 31, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- Trial start —: A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis source ↗
- FDA FDA 510(k) clearance: SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System — K253739, May 7, 2026. Applicant at approval: G source ↗
- FDA FDA 510(k) clearance: SCRIPT Implant System — K253401, Apr 29, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: AUTOBAHN Nailing System — K261043, Apr 24, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: RIB LINK Fixation System — K252166, Feb 26, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: HEDRON Cervical Spacers (HEDRON C-MIS Spacer) — K253876, Dec 22, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ExcelsiusGPS Instruments — K250599, Nov 5, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ANTHEM® Fracture System — K251161, Aug 18, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ExcelsiusXR — K241525, Jul 8, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ONVOY Acetabular System — K243456, Jun 6, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: NuVasive Pulse System — K243814, Jan 10, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ExcelsiusGPS® Instruments — K243671, Dec 20, 2024. Applicant at approval: Globus Medical, Inc. source ↗
- FDA FDA 510(k) clearance: ACTIFY Unicondylar Knee System — K241260, Dec 6, 2024. Applicant at approval: Globus Medical, Inc. source ↗
- Trial start Not phased (device or behavioral study): REFLECT Scoliosis System Post Approval Study source ↗
- Trial start Not phased (device or behavioral study): Prospective Robotic Global Research Study (PROGRESS) source ↗
- Trial start Not phased (device or behavioral study): Amnios™ RT Outcomes Study source ↗
- Trial start Not phased (device or behavioral study): Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies source ↗
- Trial start —: Patient Outcomes Using an Expandable Spacer source ↗
- Trial start Not phased (device or behavioral study): A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System source ↗
- Trial start —: A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up. source ↗
- Trial start —: Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK source ↗
- Trial start Not phased (device or behavioral study): Study of an Expandable Interbody Device for the Lumbar Spine source ↗
- Trial start —: INDEPENDENCE Spacer for Lumbar Fusion source ↗
Upcoming milestones
- Jan 30, 2027 (ESTIMATED) · · A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis · NCT07589023
- Mar 31, 2027 (ESTIMATED) · Not phased · REFLECT Scoliosis System Post Approval Study · NCT06298812
Clinical trials (lead sponsor) 16
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07589023 | A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis | Not listed | Not yet recruiting | Jun 15, 2026 | Jan 30, 2027 (estimated) |
| NCT06298812 | REFLECT Scoliosis System Post Approval Study | Not phased (device or behavioral study) | Recruiting | Apr 8, 2024 | Mar 31, 2027 (estimated) |
| NCT04088383 | Amnios™ RT Outcomes Study | Not phased (device or behavioral study) | Completed | Sep 10, 2019 | Nov 30, 2022 (actual) |
| NCT04257279 | Prospective Robotic Global Research Study (PROGRESS) | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Dec 18, 2019 | 2021-12 (estimated) |
| NCT03162666 | Patient Outcomes Using an Expandable Spacer | Not listed | Withdrawn | Feb 28, 2017 | Nov 6, 2020 (estimated) |
| NCT02184520 | A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System | Not phased (device or behavioral study) | Terminated | Apr 19, 2016 | Oct 20, 2016 (actual) |
| NCT02075554 | Study of an Expandable Interbody Device for the Lumbar Spine | Not phased (device or behavioral study) | Completed | 2012-07 | 2016-11 (actual) |
| NCT01861899 | Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK | Not listed | Completed | May 2, 2013 | Jul 5, 2018 (actual) |
| NCT00401518 | A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis | Not phased (device or behavioral study) | Completed | 2006-10 | 2017-08 (actual) |
| NCT01441999 | Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection | Not phased (device or behavioral study) | Withdrawn | 2011-10 | 2016-12 (actual) |
| NCT01198470 | TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study | Not phased (device or behavioral study) | Completed | 2010-09 | 2016-12 (actual) |
| NCT01156675 | Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer | Not phased (device or behavioral study) | Terminated | 2008-06 | 2015-07 (actual) |
| NCT03371316 | Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies | Not phased (device or behavioral study) | Withdrawn | Jan 20, 2018 | Jan 30, 2018 (actual) |
| NCT00882661 | SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study | Not phased (device or behavioral study) | Completed | 2005-07 | 2010-04 (actual) |
| NCT02299323 | INDEPENDENCE Spacer for Lumbar Fusion | Not listed | Completed | 2012-01 | 2016-08 (actual) |
| NCT02388022 | A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up. | Not listed | Completed | 2014-01 | 2015-01 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: TRIVANCE Hip Stem — K254043, Aug 4, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) — K262251, Jul 31, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System — K253739, May 7, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: SCRIPT Implant System — K253401, Apr 29, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: AUTOBAHN Nailing System — K261043, Apr 24, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: RIB LINK Fixation System — K252166, Feb 26, 2026. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: HEDRON Cervical Spacers (HEDRON C-MIS Spacer) — K253876, Dec 22, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ExcelsiusGPS Instruments — K250599, Nov 5, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ANTHEM® Fracture System — K251161, Aug 18, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ExcelsiusXR — K241525, Jul 8, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ONVOY Acetabular System — K243456, Jun 6, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: NuVasive Pulse System — K243814, Jan 10, 2025. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ExcelsiusGPS® Instruments — K243671, Dec 20, 2024. Applicant at approval: Globus Medical, Inc. source ↗
- FDA 510(k) clearance: ACTIFY Unicondylar Knee System — K241260, Dec 6, 2024. Applicant at approval: Globus Medical, Inc. source ↗
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