# K223150: APS Metal Plate & Screw System - Pathway: 510(k) (Traditional) - Applicant: A Plus Biotechnology Co., Ltd. - Decided: Aug 24, 2023 after 323 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 K000684 (2000). 51 ancestors in all. No later device cites it as a predicate yet. 0 of 52 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 5. - K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5. - K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5. - K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 5. - K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 5. - K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 5. - K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 5. - K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 5. - K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 5. - K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 5. - K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 6. - K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 6. - K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 6. - K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 6. - K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 6. - K091644: Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates, Synthes (Usa) (2009) Summary page 6. - K131186: Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System, Synthes (USA) Products, LLC (2013) Summary page 6. - K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 6. ## Indications for use Locking Screw: The locking screws, in combination with the appropriate locking plate, are indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone of the hand, wrist, foot, and ankle. Cortex Screw: The Cortex Screw is indicated to be used with the APS Metal Plate & Screw System for the fixation of fractures, osteotomies, non-unions, replantations, and fusions involving small bones and bone fragments, especially in osteopenic conditions. Examples include, but are not limited to, the hand, wrist, foot, and ankle. Star Cancellous Screw: The Star Cancellous Screw is indicated for the fixation of fractures, osteotomies, and non-unions involving the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, and distal tibia, fibula, particularly in osteopenic bone. APS HLR Screw: The APS HLR Screw is indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments, including joint fusions (arthrodesis) in the foot and fixation of intra-articular fractures of the humerus, femur, and tibia. Distal CAS Locking Plate: The Distal CAS Locking Plate is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the distal (lateral) clavicle. Distal Clavicle Hook Locking Plate | Clavicle Anatomical Midshaft Locking Plate: The Distal Clavicle Hook Locking Plate and Clavicle Anatomical Midshaft Locking Plate are indicated for the fixation of distal (lateral) clavicle fractures, mid-shaft clavicle fractures, and dislocations of the acromioclavicular joint. Distal Medial Humeral Locking Plate | Proximal Humeral Locking Plate: The Distal Medial Humeral Locking Plate and Proximal Humeral Locking Plate are indicated for fractures and fracture dislocations, osteotomies, and non-unions of the distal (medial) and proximal humerus, particularly in osteopenic bone. Small ABS Locking Plate | Dynamic Compression Locking Plate: The Small ABS Locking Plate and Dynamic Compression Locking Plate are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone. Distal Radial Locking Plate | Trident Distal Radial Locking Plate: The Distal Radial Locking Plate and Trident Distal Radial Locking Plate are indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. Distal Lateral Femoral Locking Plate: The Distal Lateral Femoral Locking Plate is indicated for buttressing multi-fragmentary distal femur fractures, including supracondylar, intra-articular and extra-articular condylar, peri-prosthetic fractures, and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur. Large ABS Locking Plate: The Large ABS Locking Plate is indicated for fixation of various long bones, such as the humerus, femur, and tibia. It is also for use in the fixation of osteopenic bone and fixation of non-unions or mal-unions. Distal FDH Locking Plate: The Distal FDH Locking Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. Distal Tibia Locking Plate System (Antero Lateral Distal Tibial Locking Plate, Distal Medial Tibial Locking Plate): The Distal Tibia Locking Plate System is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone. Proximal Medial Tibial Locking Plate: The Proximal Medial Tibial Locking Plate is indicated for buttressing metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, and medial split fractures with associated depression fractures of the medial tibial plateau. Calcaneal Locking Plate: The Calcaneal Locking Plate is indicated for addressing complex fractures and osteotomies of the calcaneus, including, but not limited to, extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fractures. Distal RAF Locking Plate: The Distal RAF Locking Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. Mini Locking Plate System: The Mini Locking Plate System is indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Source page: https://510kreport.com/device/K223150 Methodology: https://510kreport.com/methodology