Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Globus Medical, Inc. · Predicate Candidate Screening
174 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
252 days90th percentile
174clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 | 230 | 0 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACT | Globus Medical, Inc. | 2026-07-31 | 30 | 0 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilizat | Globus Medical, Inc. | 2026-05-07 | 164 | 0 |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026-04-29 | 211 | 0 |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | 2026-04-24 | 24 | 0 |
| K252166 | RIB LINK™ Fixation System | Globus Medical, Inc. | 2026-02-26 | 231 | 0 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025-12-22 | 18 | 0 |
| K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 2025-11-05 | 250 | 0 |
| K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | 2025-08-18 | 125 | 0 |
| K241525 | ExcelsiusXR™ | Globus Medical, Inc. | 2025-07-08 | 404 | 0 |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025-06-06 | 211 | 0 |
| K243814 | NuVasive Pulse System | Globus Medical, Inc. | 2025-01-10 | 30 | 0 |
| K243671 | ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024-12-20 | 23 | 0 |
| K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024-12-06 | 214 | 0 |
| K234035 | COSINE™ Spacer | Globus Medical, Inc. | 2024-09-06 | 261 | 0 |
| K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | Globus Medical, Inc. | 2024-06-20 | 101 | 0 |
| K240721 | ExcelsiusFlex™ | Globus Medical, Inc. | 2024-06-14 | 88 | 0 |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 2024-06-03 | 56 | 0 |
| K240568 | DuraPro™ Oscillating System | Globus Medical, Inc. | 2024-04-29 | 60 | 0 |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGP | Globus Medical, Inc. | 2024-03-14 | 265 | 0 |
| K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024-02-09 | 88 | 0 |
| K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024-01-25 | 64 | 0 |
| K232318 | VICTORY™ Lumbar Plate System | Globus Medical, Inc. | 2023-10-31 | 89 | 0 |
| K231333 | STRETTO™ Cable System | Globus Medical, Inc. | 2023-08-04 | 88 | 0 |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/ | Globus Medical, Inc. | 2023-08-03 | 399 | 0 |
| K230565 | HILINE™ Fixation System | Globus Medical, Inc. | 2023-04-20 | 50 | 0 |
| K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022-12-19 | 446 | 0 |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expand | Globus Medical, Inc. | 2022-10-21 | 84 | 0 |
| K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022-10-03 | 298 | 0 |
| K220659 | AUTOBAHN(R) EVO Femoral Nails | Globus Medical, Inc. | 2022-09-09 | 186 | 0 |
| K222409 | CAPTIVATE® Compression Screws | Globus Medical, Inc. | 2022-09-08 | 29 | 0 |
| K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | Globus Medical, Inc. | 2022-08-11 | 57 | 0 |
| K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022-01-26 | 75 | 0 |
| K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021-10-01 | 58 | 0 |
| K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021-08-25 | 91 | 1 |
| K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navi | Globus Medical, Inc. | 2021-08-18 | 55 | 0 |
| K210912 | Excelsius3D | Globus Medical, Inc. | 2021-08-12 | 136 | 0 |
| K201733 | Provident II Hip Stems | Globus Medical, Inc. | 2021-07-14 | 384 | 0 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT | Globus Medical, Inc. | 2021-02-02 | 88 | 0 |
| K203153 | CREO Stabilization System, Navigation Instruments, Excelsius | Globus Medical, Inc. | 2021-01-19 | 89 | 0 |
| K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020-10-29 | 59 | 0 |
| K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020-07-31 | 99 | 0 |
| K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020-07-10 | 183 | 3 |
| K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020-01-14 | 161 | 0 |
| K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019-12-16 | 77 | 0 |
| K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | 2019-10-23 | 58 | 0 |
| K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019-09-18 | 117 | 0 |
| K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019-09-17 | 131 | 0 |
| K191835 | CREO Stabilization System, Navigation Instruments, Excelsius | Globus Medical, Inc. | 2019-08-06 | 28 | 0 |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019-07-24 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda