Nextremity Solutions, Inc.: FDA clearances and approvals
Nextremity Solutions, Inc. has 20 FDA 510(k) clearances (first 2011, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time: 92 days. Since 2017 its median was 92 days, against 96 days for all cleared 510(k)s in the same product codes. openFDA lists 15 product recalls by a recalling firm named Nextremity Solutions, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 90 |
| 2013 | 1 | 134 |
| 2014 | 1 | 54 |
| 2015 | 2 | 115 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 90 |
| 2019 | 2 | 105 |
| 2020 | 3 | 113 |
| 2021 | 4 | 84 |
| 2022 | 3 | 154 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Nextremity Solutions, Inc.'s cleared 510(k)s took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 11 | 11 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| JDR | Staple, Fixation, Bone | 3 | 3 |
Review panels
- Orthopedic (20)
Most recent Nextremity Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221610 | Nextra CH Cannulated Hammertoe System | HWC | 2022-11-04 | 154 |
| K212979 | CalcShift Displacement Calcaneal Osteotomy System | HRS | 2022-05-20 | 245 |
| K220181 | StealthFix Intraosseous Fixation System | JDR | 2022-03-22 | 60 |
| K213301 | InCore Subtalar System | HWC | 2021-12-21 | 81 |
| K213530 | Nextra CH Cannulated Hammertoe System | HWC | 2021-12-09 | 34 |
| K212640 | Stratum® Ankle Fusion Plating System | HRS | 2021-11-18 | 90 |
| K211996 | Nexta PEEK Hammertoe Correction System | HWC | 2021-09-23 | 87 |
| K200785 | Stratum Reduced Size Foot Plating System | HRS | 2020-07-27 | 123 |
| K200840 | DuoHex CH Cannulated Hammertoe System | HWC | 2020-06-26 | 87 |
| K200124 | InCore MPJ System | HWC | 2020-05-13 | 113 |
10 earlier clearances. See the full list in Caduvo.
Recalls
15 product recalls in 7 recall events; 7 initiated in the last five years. Most recent: 2022-02-10.
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.
Frequently asked questions
How many FDA 510(k) clearances does Nextremity Solutions, Inc. have?
Nextremity Solutions, Inc. has 20 FDA 510(k) clearances (first 2011, latest 2022), across 3 product codes in 1 review panel.
How long does FDA take to clear Nextremity Solutions, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nextremity Solutions, Inc.'s cleared 510(k)s is 92 days. Since 2017: 92 days, versus 96 days for all cleared 510(k)s in the same product codes.
What devices does Nextremity Solutions, Inc. make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 11); HRS (Plate, Fixation, Bone, 6); JDR (Staple, Fixation, Bone, 3).
Has Nextremity Solutions, Inc. had device recalls?
openFDA lists 15 product recalls in 7 recall events by a recalling firm whose name matches Nextremity Solutions, Inc; the most recent began 2022-02-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 20 Nextremity Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Nextremity Solutions, Inc.'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.