Onkos Surgical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Onkos Surgical, Inc.” (first 2016, latest 2026), plus 1 De Novo decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 59 days, against 155 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 |
|---|---|---|
| 2016 | 1 | 148 |
| 2017 | 0 | — |
| 2018 | 1 | 37 |
| 2019 | 0 | — |
| 2020 | 1 | 59 |
| 2021 | 3 | 59 |
| 2022 | 1 | 306 |
| 2023 | 1 | 89 |
| 2024 | 0 | — |
| 2025 | 1 | 33 |
| 2026 | 1 | 259 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Onkos Surgical, Inc. took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 3 |
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 3 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Onkos Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage System | QZZ | 2026-06-08 | 259 |
| K252920 | ELEOS Limb Salvage System with NanoCept® Technology | QZZ | 2025-10-15 | 33 |
| K223348 | My3D® Personalized Pelvic Reconstruction | LPH | 2023-01-30 | 89 |
| K212815 | My3D® Personalized Pelvic Reconstruction | LPH | 2022-07-06 | 306 |
| K211677 | ELEOS Limb Salvage System | KRO | 2021-07-28 | 57 |
| K203815 | ELEOS Limb Salvage System with BioGrip | JDI | 2021-06-09 | 162 |
| K203588 | ELEOS Limb Salvage System | JDI | 2021-02-05 | 59 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | JDI | 2020-12-11 | 59 |
| K180130 | ELEOS Bipolar Acetabular System | KWY | 2018-02-23 | 37 |
| K161520 | ELEOS Limb Salvage System | KRO | 2016-10-28 | 148 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210058 | De Novo | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 2024-04-05 |
Recalls
16 product recalls in 6 recall events; 13 initiated in the last five years. Most recent: 2025-07-11.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Onkos Surgical (6)
- Onkos Surgical, Inc. (5)
Frequently asked questions
How many FDA 510(k) clearances are listed under Onkos Surgical, Inc.?
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Onkos Surgical, Inc.” (first 2016, latest 2026), plus 1 De Novo decision, across 5 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 Onkos Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onkos Surgical, Inc. is 74 days. Since 2017: 59 days, versus 155 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Onkos Surgical, Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 3); QZZ (Limb And Joint Salvage Device With Coating For Bacteria Reduction, 3); KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, 2).
Next steps
- See all 10 Onkos Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Onkos Surgical, Inc.'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.