THINK Surgical, Inc.: FDA clearances and approvals
THINK Surgical, Inc. has 23 FDA 510(k) clearances (first 2015, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 57 days. Since 2017 its median was 48 days, against 106 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named THINK Surgical, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 213 |
| 2016 | 2 | 48 |
| 2017 | 1 | 21 |
| 2018 | 0 | — |
| 2019 | 3 | 139 |
| 2020 | 3 | 30 |
| 2021 | 2 | 208 |
| 2022 | 0 | — |
| 2023 | 2 | 60 |
| 2024 | 3 | 28 |
| 2025 | 4 | 59 |
| 2026 | 2 | 88 |
Review time against the same product codes
Since 2017, THINK Surgical, Inc.'s cleared 510(k)s took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 19 | 19 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| OJP | Orthopedic Computer Controlled Surgical System | 1 | 1 |
Review panels
- Orthopedic (20)
- General Hospital (3)
Most recent THINK Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261024 | TMINI Miniature Robotic System | OLO | 2026-07-24 | 116 |
| K260010 | TMINI® Miniature Robotic System | OLO | 2026-03-03 | 60 |
| K253661 | TMINI Miniature Robotic System | OLO | 2025-12-22 | 32 |
| K252544 | TMINI Miniature Robotic System | OLO | 2025-10-10 | 59 |
| K250877 | TMINI Miniature Robotic System | OLO | 2025-06-20 | 88 |
| K243481 | TMINI Miniature Robotic System | OLO | 2025-01-06 | 59 |
| K243285 | TMINI Miniature Robotic System | OLO | 2024-11-15 | 28 |
| K242264 | TMINI Miniature Robotic System | OLO | 2024-08-23 | 22 |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | OLO | 2024-07-12 | 88 |
| K232802 | TMINI Miniature Robotic System | OLO | 2023-10-12 | 30 |
13 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2026-05-08.
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
THINK Surgical, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03017261: TSolution One® Total Knee Arthroplasty (Completed, started 2017-02-18)
Frequently asked questions
How many FDA 510(k) clearances does THINK Surgical, Inc. have?
THINK Surgical, Inc. has 23 FDA 510(k) clearances (first 2015, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear THINK Surgical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across THINK Surgical, Inc.'s cleared 510(k)s is 57 days. Since 2017: 48 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does THINK Surgical, Inc. make?
Its most frequent FDA product codes are OLO (Orthopedic Stereotaxic Instrument, 19); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3); OJP (Orthopedic Computer Controlled Surgical System, 1).
Has THINK Surgical, Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches THINK Surgical, Inc; the most recent began 2026-05-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 23 THINK Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLO, THINK Surgical, 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.