Motiva USA, LLC: FDA clearances and approvals
Motiva USA, LLC has 2 FDA 510(k) clearances (first 2019, latest 2023), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time: 473 days. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 82 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 864 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Motiva USA, LLC's cleared 510(k)s took a median 473 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 1 | 0 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
| MRD | Mammary Sizer | 1 | 1 |
Review panels
Most recent Motiva USA, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211676 | Motiva Flora SmoothSilk Tissue Expander | LCJ | 2023-10-13 | 864 |
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | MRD | 2019-02-05 | 82 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230005 | PMA | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas | 2024-09-26 |
Recalls
openFDA lists no recalls under a recalling firm named Motiva USA, LLC.
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
Motiva USA, LLC is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06938399: Motiva Implants® Post-Approval Study (Recruiting, started 2025-05-01)
- NCT03579901: Study of the Safety and Effectiveness of Motiva Implants® (Active not recruiting, started 2018-04-06)
Frequently asked questions
How many FDA 510(k) clearances does Motiva USA, LLC have?
Motiva USA, LLC has 2 FDA 510(k) clearances (first 2019, latest 2023), plus 1 PMA decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Motiva USA, LLC's 510(k)s?
The median time from FDA receipt to decision across Motiva USA, LLC's cleared 510(k)s is 473 days.
What devices does Motiva USA, LLC make?
Its most frequent FDA product codes are FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled, 1); LCJ (Tissue Expander And Accessories, 1); MRD (Mammary Sizer, 1).
Has Motiva USA, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Motiva USA, LLC. Related entities may recall under other names.
Next steps
- See all 2 Motiva USA, LLC clearances with predicates and recalls
- Run predicate analysis for product code FTR, Motiva USA, LLC'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.