Osseus Fusion Systems: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Osseus Fusion Systems” (first 2013, latest 2023), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 106 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 |
|---|---|---|
| 2013 | 1 | 50 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 61 |
| 2017 | 1 | 104 |
| 2018 | 1 | 86 |
| 2019 | 1 | 84 |
| 2020 | 1 | 128 |
| 2021 | 0 | — |
| 2022 | 3 | 109 |
| 2023 | 1 | 93 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osseus Fusion Systems took a median 106 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Osseus Fusion Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223413 | Pisces-SA STANDALONE ALIF Interbody System | OVD | 2023-02-10 | 93 |
| K222107 | Black Diamond POCT Spinal System | NKG | 2022-11-03 | 108 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | OVD | 2022-05-06 | 141 |
| K213590 | Blue Topaz Sacroiliac Screw System | OUR | 2022-03-01 | 109 |
| K192495 | Black Diamond Navigation Instruments | OLO | 2020-01-17 | 128 |
| K192121 | Black Diamond Pedicle Screw System | NKB | 2019-10-29 | 84 |
| K181347 | Aries® Lumbar Interbodies | MAX | 2018-08-15 | 86 |
| K170844 | Gemini-C Hybrid Cervical Interbody System | ODP | 2017-07-03 | 104 |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | KWQ | 2016-04-26 | 61 |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | MNH | 2013-08-08 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Osseus Fusion Systems.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Osseus, LLC (2 510(k)s)
- Osseus Fusions Systems, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osseus Fusion Systems?
FDA lists 10 510(k) clearances under the applicant name “Osseus Fusion Systems” (first 2013, latest 2023), across 9 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 Osseus Fusion Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osseus Fusion Systems is 98 days. Since 2017: 106 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osseus Fusion Systems?
The most frequent FDA product codes under this applicant name are OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 10 Osseus Fusion Systems clearances with predicates and recalls
- Run predicate analysis for product code OVD, Osseus Fusion Systems'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.