Spinal Elements, Inc.: FDA clearances and approvals
Spinal Elements, Inc. has 50 FDA 510(k) clearances (first 2007, latest 2026), across 14 product codes in 2 review panels. Median 510(k) review time: 114 days. Since 2017 its median was 110 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 24 product recalls by a recalling firm named Spinal Elements, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 166 |
| 2013 | 3 | 149 |
| 2014 | 2 | 252 |
| 2015 | 3 | 71 |
| 2016 | 3 | 255 |
| 2017 | 1 | 308 |
| 2018 | 4 | 142 |
| 2019 | 3 | 94 |
| 2020 | 2 | 94 |
| 2021 | 2 | 158 |
| 2022 | 1 | 104 |
| 2023 | 3 | 62 |
| 2024 | 1 | 89 |
| 2025 | 2 | 166 |
| 2026 | 3 | 100 |
Review time against the same product codes
Since 2017, Spinal Elements, Inc.'s cleared 510(k)s took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 17 | 17 |
| NKB | Thoracolumbosacral Pedicle Screw System | 11 | 11 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 2 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Spinal Elements, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | MAX | 2026-05-15 | 87 |
| K253559 | Ventana A Anterior Lumbar Interbody System | OVD | 2026-02-25 | 100 |
| K250773 | Luna® Ti Interbody Fusion System | MAX | 2026-02-04 | 327 |
| K242527 | The Karma® Fixation System | MRW | 2025-05-21 | 268 |
| K243916 | Primus Spinal Fixation System | NKB | 2025-02-21 | 63 |
| K234150 | Lucent® XP | MAX | 2024-03-27 | 89 |
| K231593 | Sapphire X3 Anterior Cervical Plate System | KWQ | 2023-08-02 | 62 |
| K231252 | Ventana L Spinal System | MAX | 2023-06-30 | 60 |
| K222833 | Ventana C Spinal System | ODP | 2023-05-19 | 241 |
| K222516 | Mercury® II Spinal System | NKB | 2022-12-01 | 104 |
40 earlier clearances. See the full list in Caduvo.
Recalls
24 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-04-16.
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
Spinal Elements, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04984213: Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device (Completed, started 2021-08-15)
Frequently asked questions
How many FDA 510(k) clearances does Spinal Elements, Inc. have?
Spinal Elements, Inc. has 50 FDA 510(k) clearances (first 2007, latest 2026), across 14 product codes in 2 review panels.
How long does FDA take to clear Spinal Elements, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Spinal Elements, Inc.'s cleared 510(k)s is 114 days. Since 2017: 110 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Spinal Elements, Inc. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 17); NKB (Thoracolumbosacral Pedicle Screw System, 11); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4).
Has Spinal Elements, Inc. had device recalls?
openFDA lists 24 product recalls in 4 recall events by a recalling firm whose name matches Spinal Elements, Inc; the most recent began 2018-04-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 50 Spinal Elements, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spinal Elements, 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.