Cartiva, Inc.: FDA clearances and approvals
Cartiva, Inc. has 3 FDA 510(k) clearances (first 2014, latest 2019), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time: 30 days. openFDA lists 1 product recall by a recalling firm named Cartiva, Inc. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 102 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 30 |
| 2019 | 1 | 26 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cartiva, Inc.'s cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| PNW | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant | 1 | 0 |
Review panels
- Orthopedic (4)
Most recent Cartiva, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192156 | Cartiva SCI instrumentation set | QBO | 2019-09-04 | 26 |
| K181348 | Cartiva SCI Disposable Instrumentation Set | QBO | 2018-06-20 | 30 |
| K142490 | ProxiFuse Hammer Toe Device | HWC | 2014-12-15 | 102 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150017 | PMA | CARTIVA SYNTHETIC CARTILAGE IMPLANT | 2016-07-01 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-10-31.
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
Cartiva, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02978573: Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe (Completed, started 2016-10)
- NCT02391506: Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis (Completed, started 2015-07-29)
- NCT00969969: A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe (Completed, started 2009-08)
Frequently asked questions
How many FDA 510(k) clearances does Cartiva, Inc. have?
Cartiva, Inc. has 3 FDA 510(k) clearances (first 2014, latest 2019), plus 1 PMA decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Cartiva, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cartiva, Inc.'s cleared 510(k)s is 30 days.
What devices does Cartiva, Inc. make?
Its most frequent FDA product codes are QBO (Instruments Designed For Press-Fit Osteochondral Implants, 2); HWC (Screw, Fixation, Bone, 1); PNW (Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant, 1).
Has Cartiva, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Cartiva, Inc; the most recent began 2024-10-31. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 3 Cartiva, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QBO, Cartiva, 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.