Globus Medical, Inc.: FDA clearances and approvals
Globus Medical, Inc. has 174 FDA 510(k) clearances (first 2003, latest 2026), plus 2 PMA decisions, across 38 product codes in 5 review panels. Median 510(k) review time: 94 days. Since 2017 its median was 101 days, against 96 days for all cleared 510(k)s in the same product codes. openFDA lists 29 product recalls by a recalling firm named Globus Medical, Inc. It is the industry lead sponsor of 8 device clinical trials on ClinicalTrials.gov. It files with the SEC as GLOBUS MEDICAL INC (GMED).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 10 | 82 |
| 2013 | 10 | 135 |
| 2014 | 5 | 133 |
| 2015 | 4 | 133 |
| 2016 | 8 | 157 |
| 2017 | 13 | 128 |
| 2018 | 14 | 162 |
| 2019 | 13 | 90 |
| 2020 | 4 | 130 |
| 2021 | 7 | 89 |
| 2022 | 7 | 84 |
| 2023 | 4 | 88 |
| 2024 | 10 | 88 |
| 2025 | 6 | 168 |
| 2026 | 6 | 188 |
Review time against the same product codes
Since 2017, Globus Medical, Inc.'s cleared 510(k)s took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 24 | 24 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 20 | 20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 15 | 15 |
| OLO | Orthopedic Stereotaxic Instrument | 13 | 13 |
| MQP | Spinal Vertebral Body Replacement Device | 11 | 11 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 11 | 11 |
| HRS | Plate, Fixation, Bone | 8 | 8 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 7 |
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 7 | 7 |
Plus 28 more product codes.
Review panels
- Orthopedic (172)
- General Hospital (1)
- Neurology (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Globus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254043 | TRIVANCE Hip Stem | LPH | 2026-08-04 | 230 |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) | JWH | 2026-07-31 | 30 |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | NKB | 2026-05-07 | 164 |
| K253401 | SCRIPT Implant System | OVD | 2026-04-29 | 211 |
| K261043 | AUTOBAHN Nailing System | HSB | 2026-04-24 | 24 |
| K252166 | RIB LINK Fixation System | HRS | 2026-02-26 | 231 |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | OVE | 2025-12-22 | 18 |
| K250599 | ExcelsiusGPS Instruments | OLO | 2025-11-05 | 250 |
| K251161 | ANTHEM® Fracture System | HRS | 2025-08-18 | 125 |
| K241525 | ExcelsiusXR | SBF | 2025-07-08 | 404 |
164 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200022 | PMA | Simplify® Cervical Artificial Disc | 2020-09-18 |
| P100003 | PMA | SECURE-C ARTIFICIAL CERVICAL DISC | 2012-09-28 |
Recalls
29 product recalls in 6 recall events; 6 initiated in the last five years. Most recent: 2025-04-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Globus Medical, Inc. is the industry lead sponsor of 8 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06298812: REFLECT Scoliosis System Post Approval Study (Recruiting, started 2024-04-08)
- NCT02388022: A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up. (Completed, started 2014-01)
- NCT01861899: Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK (Completed, started 2013-05-02)
- NCT02075554: Study of an Expandable Interbody Device for the Lumbar Spine (Completed, started 2012-07)
- NCT02299323: INDEPENDENCE Spacer for Lumbar Fusion (Completed, started 2012-01)
SEC filings
GLOBUS MEDICAL INC (GMED): EDGAR filings, CIK 1237831. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Globus Medical, Inc. have?
Globus Medical, Inc. has 174 FDA 510(k) clearances (first 2003, latest 2026), plus 2 PMA decisions, across 38 product codes in 5 review panels.
How long does FDA take to clear Globus Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Globus Medical, Inc.'s cleared 510(k)s is 94 days. Since 2017: 101 days, versus 96 days for all cleared 510(k)s in the same product codes.
What devices does Globus Medical, Inc. make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 24); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 20); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 15).
Has Globus Medical, Inc. had device recalls?
openFDA lists 29 product recalls in 6 recall events by a recalling firm whose name matches Globus Medical, Inc; the most recent began 2025-04-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 174 Globus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Globus Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.