Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OrthoGrid Systems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | 2026-05-29 | 137 | 0 |
| K210136 | PhantomMSK Hip | OrthoGrid Systems, Inc. | 2021-02-18 | 30 | 0 |
| K192279 | PhantomMSK Trauma | OrthoGrid Systems, Inc. | 2019-12-07 | 107 | 0 |
| K182332 | PhantomMSK | OrthoGrid Systems, Inc. | 2019-02-15 | 171 | 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