Aju Pharm Co., Ltd.: FDA clearances and approvals
Aju Pharm Co., Ltd. has 10 FDA 510(k) clearances (first 2017, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time: 228 days. Since 2017 its median was 228 days, against 88 days for all cleared 510(k)s in the same product codes. openFDA lists 8 product recalls by a recalling firm named Aju Pharm Co., Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 172 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 217 |
| 2021 | 2 | 387 |
| 2022 | 0 | — |
| 2023 | 2 | 147 |
| 2024 | 1 | 267 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Aju Pharm Co., Ltd.'s cleared 510(k)s took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 5 | 5 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| HRX | Arthroscope | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Aju Pharm Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233601 | Fixone Meniscal Repair | MBI | 2024-08-02 | 267 |
| K230892 | Fixone Biocomposite Anchor | MAI | 2023-06-09 | 70 |
| K222423 | Fixone All Suture Anchor | MBI | 2023-03-23 | 224 |
| K203523 | Fixone hybrid knotless anchor | MAI | 2021-12-25 | 389 |
| K193497 | Fixone Biocomposite Interference Screw | HWC | 2021-01-05 | 385 |
| K192709 | Fixone All Suture Anchor | MBI | 2020-12-15 | 445 |
| K192484 | Fixone Biocomposite Anchor | MAI | 2020-03-11 | 183 |
| K192032 | Fixone Biocomposite Small Anchor | MAI | 2020-03-03 | 217 |
| K171299 | Fixone Biocomposite Anchor | MAI | 2017-08-24 | 113 |
| K162070 | JOINIX CANNULAR SYSTEM | HRX | 2017-03-16 | 232 |
Recalls
8 product recalls in 1 recall events; 8 initiated in the last five years. Most recent: 2025-12-17.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Aju Pharm Co., Ltd. have?
Aju Pharm Co., Ltd. has 10 FDA 510(k) clearances (first 2017, latest 2024), across 4 product codes in 1 review panel.
How long does FDA take to clear Aju Pharm Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Aju Pharm Co., Ltd.'s cleared 510(k)s is 228 days. Since 2017: 228 days, versus 88 days for all cleared 510(k)s in the same product codes.
What devices does Aju Pharm Co., Ltd. make?
Its most frequent FDA product codes are MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 5); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); HRX (Arthroscope, 1).
Has Aju Pharm Co., Ltd. had device recalls?
openFDA lists 8 product recalls in 1 recall event by a recalling firm whose name matches Aju Pharm Co., Ltd; the most recent began 2025-12-17. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Aju Pharm Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MAI, Aju Pharm Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.