Aju Pharm Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Aju Pharm Co., Ltd.” (first 2017, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 228 days. Since 2017 the median was 228 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Aju Pharm Co., Ltd. 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aju Pharm Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Aju Pharm Co., Ltd.” (first 2017, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aju Pharm Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aju Pharm Co., Ltd. is 228 days. Since 2017: 228 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aju Pharm Co., Ltd.?
The most frequent FDA product codes under this applicant name are MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 5); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); HRX (Arthroscope, 1).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.