Omnilife Science: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Omnilife Science” (first 2007, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 129 days. Since 2017 the median was 138 days, against 105 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 | 0 | — |
| 2014 | 1 | 129 |
| 2015 | 1 | 24 |
| 2016 | 0 | — |
| 2017 | 3 | 128 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 291 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Omnilife Science took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Omnilife Science 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201611 | Apex Knee System | JWH | 2021-04-02 | 291 |
| K172467 | OMNI ARC Anteverted Neck Hip Stem | LZO | 2017-12-21 | 128 |
| K171156 | OMNI Anseris Hip Stem | LZO | 2017-08-17 | 119 |
| K163332 | Apex Revision Knee System | JWH | 2017-04-26 | 149 |
| K153437 | Apex Revision Knee System | JWH | 2015-12-21 | 24 |
| K133381 | OMNI ARC MONOBLOCK HIP STEM | LZO | 2014-03-13 | 129 |
| K062489 | APEX HCLA ACETABULAR CUP LINERS | LPH | 2007-08-15 | 355 |
Recalls
17 product recalls in 12 recall events; 1 initiated in the last five years. Most recent: 2021-10-01.
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 Omnilife Science?
FDA lists 7 510(k) clearances under the applicant name “Omnilife Science” (first 2007, latest 2021), across 3 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 Omnilife Science?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omnilife Science is 129 days. Since 2017: 138 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Omnilife Science?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 3); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 3); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 1).
Next steps
- See all 7 Omnilife Science clearances with predicates and recalls
- Run predicate analysis for product code JWH, Omnilife Science'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.