Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
199 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964953 | IN-TAC BONE ANCHOR SYSTEM | Influence, Inc. | 1997-02-13 | 70 | 0 |
| K962372 | UROTAC BONE ANCHOR INSERTER | Influence, Inc. | 1996-08-19 | 61 | 0 |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Micro Surgical Instruments Corp. | 1993-08-02 | 199 | 0 |
| K834515 | FIXATION STAPLE KIT - DLIDE HAMMER | Stryker Corp. | 1984-04-23 | 124 | 0 |
| K830255 | OSTEOTOMY BONE STAPLE | Techmedica, Inc. | 1983-03-09 | 43 | 0 |
| K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | Instrument Makar, Inc. | 1983-03-09 | 28 | 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