Spineology, Inc.: FDA clearances and approvals
Spineology, Inc. has 53 FDA 510(k) clearances (first 1999, latest 2025), plus 1 De Novo decision, across 11 product codes in 2 review panels. Median 510(k) review time: 77 days. Since 2017 its median was 77 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Spineology, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 61 |
| 2013 | 5 | 75 |
| 2014 | 4 | 49 |
| 2015 | 2 | 64 |
| 2016 | 6 | 100 |
| 2017 | 11 | 77 |
| 2018 | 6 | 49 |
| 2019 | 3 | 29 |
| 2020 | 0 | — |
| 2021 | 1 | 29 |
| 2022 | 1 | 235 |
| 2023 | 2 | 168 |
| 2024 | 0 | — |
| 2025 | 2 | 197 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Spineology, Inc.'s cleared 510(k)s took a median 77 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 | 22 | 22 |
| NKB | Thoracolumbosacral Pedicle Screw System | 12 | 12 |
| OLO | Orthopedic Stereotaxic Instrument | 5 | 5 |
| OQB | Intervertebral Body Graft Containment Device | 4 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| EZX | Mesh, Surgical, Metal | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Spineology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | OQB | 2025-12-15 | 231 |
| K251943 | Spineology Navigation Instruments | OLO | 2025-12-04 | 163 |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | OQB | 2023-11-01 | 212 |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | OQB | 2023-10-18 | 124 |
| K213876 | Spineology Navigation Instruments | OLO | 2022-08-05 | 235 |
| K210155 | Duo Expandable Interbody Fusion System | MAX | 2021-02-19 | 29 |
| K192047 | Rampart One Lumbar Interbody Fusion System | OVD | 2019-08-23 | 23 |
| K191091 | Rampart One Lumbar Interbody Fusion System | OVD | 2019-05-23 | 29 |
| K190055 | Duo Lumbar Interbody Fusion Device | MAX | 2019-03-07 | 55 |
| K182322 | Duo Lumbar Interbody Fusion Device | MAX | 2018-10-24 | 58 |
43 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200010 | De Novo | Intervertebral Body Graft Containment Device | 2020-09-18 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-09-16.
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
Spineology, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02347410: Spineology Clinical Outcomes Trial: An IDE Investigation (Completed, started 2015-01-22)
- NCT00764491: OptiMesh® for Lumbar Interbody Fusion Trial (OLIF) (Completed, started 2003-07)
Frequently asked questions
How many FDA 510(k) clearances does Spineology, Inc. have?
Spineology, Inc. has 53 FDA 510(k) clearances (first 1999, latest 2025), plus 1 De Novo decision, across 11 product codes in 2 review panels.
How long does FDA take to clear Spineology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Spineology, Inc.'s cleared 510(k)s is 77 days. Since 2017: 77 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Spineology, Inc. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 22); NKB (Thoracolumbosacral Pedicle Screw System, 12); OLO (Orthopedic Stereotaxic Instrument, 5).
Has Spineology, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Spineology, Inc; the most recent began 2024-09-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 53 Spineology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spineology, 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.