Wishbone Medical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Wishbone Medical, Inc.” (first 2017, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 78 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 78 |
| 2018 | 1 | 196 |
| 2019 | 1 | 271 |
| 2020 | 2 | 158 |
| 2021 | 0 | — |
| 2022 | 2 | 56 |
| 2023 | 2 | 29 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wishbone Medical, Inc. took a median 78 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Wishbone Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231461 | Smart Correction System (HA Half Pins) | KTT | 2023-06-16 | 28 |
| K230527 | WishBone Medical Plate and Screw System | HRS | 2023-03-29 | 30 |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | KTT | 2022-06-06 | 25 |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate | HRS | 2022-01-27 | 87 |
| K203467 | WishBone Medical Plate and Screw System | HWC | 2020-12-23 | 28 |
| K193368 | Smart Correction System | KTT | 2020-09-18 | 288 |
| K182704 | WishBone Guided Growth System | OBT | 2019-06-25 | 271 |
| K180736 | WishBone Medical Plate and Screw System | HRS | 2018-10-04 | 196 |
| K173013 | WishBone K-Wire System | HTY | 2017-12-14 | 78 |
Recalls
3 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2024-04-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wishbone SA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wishbone Medical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Wishbone Medical, Inc.” (first 2017, latest 2023), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wishbone Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wishbone Medical, Inc. is 78 days. Since 2017: 78 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wishbone Medical, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 9 Wishbone Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Wishbone Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.