# K254053: APS Spear Locking Plate

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Biotechnology Co., Ltd.
- Decided: Mar 17, 2026 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954385 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101962: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2010) Summary page 5.
- K033975: Synthes 2.4 MM Titanium (TI.) Locking Screws, Synthes (Usa) (2004) Summary page 5.

## Indications for use
The APS Spear Locking Plate System is indicated for use in small bone reconstruction, corrective osteotomies, and fracture fixation. 2.4mm Locking Screw The 2.4mm Locking Screw is intended for use with the Spear Locking Plate in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation. 2.7mm Continuous Locking Screw The 2.7mm Continuous Locking Screw is intended for use with the Spear Locking Plate, for fixation and compression at the osteotomy or fracture site. It is suitable for metacarpal and metatarsal corrective osteotomies and fracture stabilization. Spear Locking Plate The Spear Locking Plate is intended for use in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation. Spear Locking Plate II The Spear Locking Plate II is intended for metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.

Source page: https://510kreport.com/device/K254053
Methodology: https://510kreport.com/methodology