# 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

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Biotechnology Co., Ltd.
- Decided: Dec 11, 2025 after 91 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: 1 generation back to K023941 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 6.

## Indications for use
The 4.5 mm Cortical Screw is intended for use only in conjunction with compatible plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures and bone fissures where high-strength cortical fixation is required as part of the plate-and-screw construct. The screw provides stable support at the fixation site when used as a component of the APS Osteotomy Fixation System. This screw is not intended for standalone use. The 5.0 mm Locking Screw is intended for use only with compatible locking plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures requiring angular stability and reliable screw-plate interface fixation as part of the system construct. The locking mechanism is designed to reduce screw loosening and enhance stability at the fixation site. This screw is not intended for standalone use. The Proximal Medial Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy procedures, providing fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures on the proximal medial tibia. The “Proximal Medial Tibial Osteotomy Locking Plate, Small” is designed for high tibial osteotomy. It is indicated for use in deformity correction and osteotomy, providing fixation in general and reconstructive surgeries, as well as bone fusion or osteotomy procedures. The Proximal Lateral Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the proximal lateral tibia, offering fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures. The Distal Medial Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal medial femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures. The Distal Lateral Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal lateral femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.

Source page: https://510kreport.com/device/K252897
Methodology: https://510kreport.com/methodology