Cymedica Orthopedics, Inc.: FDA clearances and approvals
Cymedica Orthopedics, Inc. has 5 FDA 510(k) clearances (first 2015, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time: 43 days. Since 2017 its median was 59 days, against 130 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 43 |
| 2016 | 1 | 29 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 94 |
| 2022 | 1 | 59 |
| 2023 | 1 | 23 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cymedica Orthopedics, Inc.'s cleared 510(k)s 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 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 4 | 4 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Physical Medicine (4)
- Neurology (1)
Most recent Cymedica Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230533 | Motive Electrode | GXY | 2023-03-22 | 23 |
| K220738 | Motive Knee Wrap | IPF | 2022-05-12 | 59 |
| K210604 | Intellihab System | IPF | 2021-06-03 | 94 |
| K163067 | CyMedica e-vive System; CY-1000 | IPF | 2016-12-01 | 29 |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator | IPF | 2015-04-02 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Cymedica Orthopedics, Inc..
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
Cymedica Orthopedics, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04367597: Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis (Completed, started 2020-04-20)
- NCT04128618: Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain (Completed, started 2019-10-08)
- NCT03980964: Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients (Completed, started 2019-06-07)
Frequently asked questions
How many FDA 510(k) clearances does Cymedica Orthopedics, Inc. have?
Cymedica Orthopedics, Inc. has 5 FDA 510(k) clearances (first 2015, latest 2023), across 2 product codes in 2 review panels.
How long does FDA take to clear Cymedica Orthopedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cymedica Orthopedics, Inc.'s cleared 510(k)s is 43 days. Since 2017: 59 days, versus 130 days for all cleared 510(k)s in the same product codes.
What devices does Cymedica Orthopedics, Inc. make?
Its most frequent FDA product codes are IPF (Stimulator, Muscle, Powered, 4); GXY (Electrode, Cutaneous, 1).
Has Cymedica Orthopedics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cymedica Orthopedics, Inc. Related entities may recall under other names.
Next steps
- See all 5 Cymedica Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Cymedica Orthopedics, 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.