# Aju Pharm Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 10 (2017–2024): 10 510(k) clearances
- Product codes: MAI (5), MBI (3), HWC (1), HRX (1)
- 510(k) review time since 2016: median 228 days, against 81 for FDA's reviews in the same codes and years (0 of 10 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Conmed Corporation: 1 (https://510kreport.com/company/conmed)
- Depuy Mitek, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Acufex Microsurgical, Inc.: 1 (https://510kreport.com/company/acufex-microsurgical)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)

## Firms that cite its devices most
- B-One Ortho, Corp.: 5 (https://510kreport.com/company/b-one-ortho)
- Osteonic Co., Ltd.: 1 (https://510kreport.com/company/osteonic)
- Healthium Medtech Limited: 1 (https://510kreport.com/company/healthium-medtech)

## Its most-cited devices
- K192709: Fixone All Suture Anchor (2020), cited by 3
- K192032: Fixone Biocomposite Small Anchor (2020), cited by 2
- K192484: Fixone Biocomposite Anchor (2020), cited by 2
- K171299: Fixone Biocomposite Anchor (2017), cited by 1
- K203523: Fixone hybrid knotless anchor (2021), cited by 1
- K193497: Fixone Biocomposite Interference Screw (2021), cited by 1

## Recent decisions
- K233601: Fixone Meniscal Repair (Aug 2, 2024)
- K230892: Fixone Biocomposite Anchor (Jun 9, 2023)
- K222423: Fixone All Suture Anchor (Mar 23, 2023)
- K203523: Fixone hybrid knotless anchor (Dec 25, 2021)
- K193497: Fixone Biocomposite Interference Screw (Jan 5, 2021)
- K192709: Fixone All Suture Anchor (Dec 15, 2020)
- K192484: Fixone Biocomposite Anchor (Mar 11, 2020)
- K192032: Fixone Biocomposite Small Anchor (Mar 3, 2020)

Source page: https://510kreport.com/company/aju-pharm