# A Plus Biotechnology Co., Ltd.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 3 (2023–2026): 3 510(k) clearances
- Product codes: HRS (3)
- 510(k) review time since 2016: median 91 days, against 90 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 21 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 18 (https://510kreport.com/company/synthes-usa)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Acu Med, Inc.: 1 (https://510kreport.com/company/acu-med)
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)

## Recent decisions
- K254053: APS Spear Locking Plate (Mar 17, 2026)
- K252897: APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista (Dec 11, 2025)
- K223150: APS Metal Plate & Screw System (Aug 24, 2023)

Source page: https://510kreport.com/company/a-plus-biotechnology