Chrysalis Intelligence · Sponsors · Globus Medical, Inc.

Globus Medical, Inc.

Audubon, PA, US · 44 510(k) clearances · 1 PMAs · 28 recalls (1 Class I)

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Total clearances
44
2020-01-14 → 2026-08-04
Last 12 months
8
Product codes
21
Most recent
2026-08-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OLO Orthopedic Stereotaxic Instrument Class II Neurology 8 2025-11-05
HRS Plate, Fixation, Bone Class II Orthopedic 5 2026-02-26
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II Orthopedic 4 2026-08-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 4 2024-09-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II Orthopedic 2 2026-07-31
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 2 2026-05-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 2 2026-04-29
HSB Rod, Fixation, Intramedullary And Accessories Class II Orthopedic 2 2026-04-24
NKG Posterior Cervical Screw System Class II Orthopedic 2 2024-03-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 2 2024-01-25
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Class II Orthopedic 1 2025-12-22
SBF Orthopedic Augmented Reality Class II Neurology 1 2025-07-08
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class II Orthopedic 1 2024-12-06
HTN Washer, Bolt Nut Class II Orthopedic 1 2024-06-03
JDQ Cerclage, Fixation Class II Orthopedic 1 2023-08-04
OWI Bone Fixation Cerclage, Sublaminar Class II Orthopedic 1 2023-04-20
PGM Growing Rod System Class II Orthopedic 1 2022-12-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 1 2022-10-21
HWC Screw, Fixation, Bone Class II Orthopedic 1 2022-09-08
FMF Syringe, Piston Class II General Hospital 1 2022-08-11
OWB Interventional Fluoroscopic X-Ray System Class II Radiology 1 2021-08-12
Class III

PMA approvals (1)

Total PMA records
1
Originals + supplements
Distinct product codes
1
First decision
2023-06-12
Most recent
2023-06-12
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2023-06-12 P100003-S008 SECURE®-C Cervical Artificial Disc Normal 180 Day Track No User Fee MJO Prosthesis, Intervertebral Disc Unknown
Safety

Recalls (28)

Class I (serious)
1
Risk of injury / death
Total recalls
28
Currently ongoing
6
Most recent
2025-04-03
DateSeverityStatusRecall # ProductCodeReason
2025-04-03 Class II Ongoing Z-1657-2025 MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; — Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus t…
2023-12-15 Class II Ongoing Z-1007-2024 ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 — Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilizatio…
2023-12-11 Class II Ongoing Z-0997-2024 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the Ex… — Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
2023-12-11 Class II Ongoing Z-0996-2024 Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices … — Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
2023-12-11 Class II Ongoing Z-0995-2024 Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w… — Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
2023-12-07 Class I Ongoing Z-0642-2024 ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 — A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, w…
2020-07-22 Class II Terminated Z-2871-2020 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2870-2020 ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2869-2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2868-2020 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2867-2020 ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2866-2020 ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2865-2020 ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2864-2020 ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2863-2020 ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2862-2020 ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2861-2020 ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2860-2020 ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2859-2020 ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2858-2020 ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2857-2020 ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2856-2020 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2855-2020 ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2854-2020 ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2853-2020 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2852-2020 ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2851-2020 ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
2020-07-22 Class II Terminated Z-2850-2020 ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molyb…
Filings

All 510(k) clearances (44)

Date K-number Device Code Class Specialty
2026-08-04 K254043 TRIVANCE™ Hip Stem LPH Class II Orthopedic
2026-07-31 K262251 ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) JWH Class II Orthopedic
2026-05-07 K253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System NKB Class II Orthopedic
2026-04-29 K253401 SCRIPT™ Implant System OVD Class II Orthopedic
2026-04-24 K261043 AUTOBAHN™ Nailing System HSB Class II Orthopedic
2026-02-26 K252166 RIB LINK™ Fixation System HRS Class II Orthopedic
2025-12-22 K253876 HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) OVE Class II Orthopedic
2025-11-05 K250599 ExcelsiusGPS™ Instruments OLO Class II Neurology
2025-08-18 K251161 ANTHEM® Fracture System HRS Class II Orthopedic
2025-07-08 K241525 ExcelsiusXR™ SBF Class II Neurology
2025-06-06 K243456 ONVOY™ Acetabular System LPH Class II Orthopedic
2025-01-10 K243814 NuVasive Pulse System OLO Class II Neurology
2024-12-20 K243671 ExcelsiusGPS® Instruments OLO Class II Neurology
2024-12-06 K241260 ACTIFY™ Unicondylar Knee System HSX Class II Orthopedic
2024-09-06 K234035 COSINE™ Spacer MAX Class II Orthopedic
2024-06-20 K240669 ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System JWH Class II Orthopedic
2024-06-14 K240721 ExcelsiusFlex™ OLO Class II Neurology
2024-06-03 K240947 TENSOR® Suture Button System HTN Class II Orthopedic
2024-04-29 K240568 DuraPro™ Oscillating System OLO Class II Neurology
2024-03-14 K231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments NKG Class II Orthopedic
2024-02-09 K233638 VERZA™ High Speed Drills OLO Class II Neurology
2024-01-25 K233735 ADIRA™ Lateral Plate System KWQ Class II Orthopedic
2023-10-31 K232318 VICTORY™ Lumbar Plate System KWQ Class II Orthopedic
2023-08-04 K231333 STRETTO™ Cable System JDQ Class II Orthopedic
2023-08-03 K221894 Lumbar Expandable lnterbody Spacers -Additional Indications/Implants MAX Class II Orthopedic
2023-04-20 K230565 HILINE™ Fixation System OWI Class II Orthopedic
2022-12-19 K213196 MARVEL™ Growing Rods PGM Class II Orthopedic
2022-10-21 K222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments ODP Class II Orthopedic
2022-10-03 K213842 ONVOY Acetabular System LPH Class II Orthopedic
2022-09-09 K220659 AUTOBAHN(R) EVO Femoral Nails HSB Class II Orthopedic
2022-09-08 K222409 CAPTIVATE® Compression Screws HWC Class II Orthopedic
2022-08-11 K221737 InstaFill Graft Delivery System, SIGNIFY Bioactive FMF Class II General Hospital
2022-01-26 K213591 ANTHEM® Fracture System HRS Class II Orthopedic
2021-10-01 K212433 Anthem Fracture System HRS Class II Orthopedic
2021-08-25 K211616 ExcelsiusHub OLO Class II Neurology
2021-08-18 K211957 QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments NKG Class II Orthopedic
2021-08-12 K210912 Excelsius3D OWB Class II Radiology
2021-07-14 K201733 Provident II Hip Stems LPH Class II Orthopedic
2021-02-02 K203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers MAX Class II Orthopedic
2021-01-19 K203153 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS NKB Class II Orthopedic
2020-10-29 K202496 ANTHEM Fracture System HRS Class II Orthopedic
2020-07-31 K201087 CORBEL Spacers OVD Class II Orthopedic
2020-07-10 K200047 ExcelsiusGPS Cranial 1.0 Module OLO Class II Neurology
2020-01-14 K192115 SABLE Expandable Spacer MAX Class II Orthopedic
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence