Genesys Spine: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Genesys Spine” (first 2010, latest 2025), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 88 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 280 |
| 2014 | 2 | 302 |
| 2015 | 2 | 130 |
| 2016 | 5 | 168 |
| 2017 | 3 | 38 |
| 2018 | 3 | 103 |
| 2019 | 4 | 58 |
| 2020 | 1 | 218 |
| 2021 | 0 | — |
| 2022 | 1 | 56 |
| 2023 | 1 | 35 |
| 2024 | 1 | 142 |
| 2025 | 2 | 130 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Genesys Spine took a median 88 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 | 8 | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 | 6 |
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 6 | 6 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OUR | Sacroiliac Joint Fixation | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (31)
Most recent Genesys Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252322 | SIros-X System | OUR | 2025-10-22 | 89 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | OVE | 2025-02-07 | 170 |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | OLO | 2024-03-29 | 142 |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | OVE | 2023-12-13 | 35 |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | MAX | 2022-03-09 | 56 |
| K191489 | Genesys Spine 3DP Cervical Interbody System | OVE | 2020-01-08 | 218 |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | MAX | 2019-12-12 | 409 |
| K192678 | Genesys Spine Binary® Lumbar Plate System | KWQ | 2019-10-24 | 28 |
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | OUR | 2019-09-26 | 87 |
| K192076 | Binary® Anterior Cervical Plate System | KWQ | 2019-08-29 | 27 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Genesys Spine.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Genesys Spine?
FDA lists 31 510(k) clearances under the applicant name “Genesys Spine” (first 2010, latest 2025), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genesys Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genesys Spine is 106 days. Since 2017: 88 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Genesys Spine?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 8); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 6); NKB (Thoracolumbosacral Pedicle Screw System, 6).
Next steps
- See all 31 Genesys Spine clearances with predicates and recalls
- Run predicate analysis for product code MAX, Genesys Spine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.