Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aju Pharm Co., Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
232 daysmedian FDA review time
445 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233601 | Fixone Meniscal Repair | Aju Pharm Co., Ltd. | 2024-08-02 | 267 | 8 |
| K230892 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2023-06-09 | 70 | 8 |
| K222423 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | 2023-03-23 | 224 | 8 |
| K203523 | Fixone hybrid knotless anchor | Aju Pharm Co., Ltd. | 2021-12-25 | 389 | 8 |
| K193497 | Fixone Biocomposite Interference Screw | Aju Pharm Co., Ltd. | 2021-01-05 | 385 | 8 |
| K192709 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | 2020-12-15 | 445 | 0 |
| K192484 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2020-03-11 | 183 | 0 |
| K192032 | Fixone Biocomposite Small Anchor | Aju Pharm Co., Ltd. | 2020-03-03 | 217 | 0 |
| K171299 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2017-08-24 | 113 | 0 |
| K162070 | JOINIX CANNULAR SYSTEM | Aju Pharm Co., Ltd. | 2017-03-16 | 232 | 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