Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wishbone Medical, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
288 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023-06-16 | 28 | 0 |
| K230527 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2023-03-29 | 30 | 0 |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half | Wishbone Medical, Inc. | 2022-06-06 | 25 | 0 |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7- | Wishbone Medical, Inc. | 2022-01-27 | 87 | 0 |
| K203467 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2020-12-23 | 28 | 0 |
| K193368 | Smart Correction System | Wishbone Medical, Inc. | 2020-09-18 | 288 | 1 |
| K180736 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2018-10-04 | 196 | 0 |
| K173013 | WishBone K-Wire System | Wishbone Medical, Inc. | 2017-12-14 | 78 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda