A Plus Biotechnology Co., Ltd. · Class II · Cleared Mar 17, 2026
| K-number | K254053 |
| Device name | APS Spear Locking Plate |
| Applicant | A Plus Biotechnology Co., Ltd. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The APS Spear Locking Plate System is a metallic bone fixation device used for small bone reconstruction, corrective osteotomies, and fracture fixation in the hand and foot. The system comprises titanium alloy plates and locking screws (2.4mm and 2.7mm) that create fixed-angle constructs to stabilize bone fragments and promote healing.
The device is manufactured from Ti-6Al-4V ELi alloy (ASTM F136, ISO 5832-3), a biocompatible material proven in orthopedic implants. The system uses threaded locking holes in anatomically contoured titanium plates with matching locking screws to achieve fixed-angle stability. Components are CNC-machined, surface-finished, laser-marked, and sterilized by healthcare providers using moist heat (ISO 17665).
Mechanical testing per ASTM F382 (plate bending), ASTM F543 (screw strength and insertion/removal torque), and a construct-level test simulating distal metatarsal osteotomy with lateral-to-medial displacement-controlled static loading and cyclic loading (0 to 31 N, 0.5 Hz, 1,000 cycles).
The APS Spear Locking Plate System is substantially equivalent to predicate devices (Mini MaxLock Extreme Plating System K101962 and Synthes 2.4mm Titanium Locking Screws K033975) in intended use, materials, and performance. Both use comparable titanium alloy construction with locking-plate technology for small bone fixation. Mechanical testing demonstrates equivalent strength, stability, and fatigue resistance, supporting safety and effectiveness comparable to the predicates.
View the full FDA submission: accessdata.fda.gov