Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JOF · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
265 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200532 | StarPore | Anatomics Pty, Ltd. | 2020-06-02 | 92 | 0 |
| K171037 | PoreStar Patient Specific Implant | Anatomics Pty, Ltd. | 2017-12-27 | 265 | 0 |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | Porex Surgical, Inc. | 2009-02-03 | 57 | 0 |
| K002629 | SILMAX CONTOUR CARVING BLOCK IMPLANT | Pillar Surgical, Inc. | 2000-11-20 | 89 | 0 |
| K771726 | BIOSPONGE STAPES PISTON | Xomed, Inc. | 1977-09-26 | 13 | 0 |
| K771727 | BIOSPONGE RECONSTRUCTION DISCS | Xomed, Inc. | 1977-09-26 | 13 | 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