APS Metal Plate & Screw System
by A Plus Biotechnology Co., Ltd. Taiwan 510(k)
510(k) K223150 Product code HRS
Overview
The APS Metal Plate & Screw System is an orthopedic fixation device classified under the FDA’s Product Code HRS. It consists of anatomically contoured metallic plates and screws designed for internal bone fixation, fracture stabilization, and arthrodesis. The system includes both locking and non-locking screw holes to accommodate cortical and locking screws, ensuring compression and stability at the fracture site. Its design supports secure alignment and rigid fixation of bone fragments, facilitating proper healing.
This system is supplied sterile and intended for single-use in surgical settings. It is regulated under FDA 510(k) clearance (K223150) as substantially equivalent to predicate devices, with approval for orthopedic applications. The plates and screws are manufactured to meet strict mechanical performance standards, ensuring reliability in clinical use. Storage and handling follow standard sterile orthopedic protocols to maintain integrity until surgical implementation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223150 | Date24 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from A Plus Biotechnology Co., Ltd.
Questions
What types of bone procedures is the APS Metal Plate & Screw System designed to support, and how does its design help with healing?
The APS Metal Plate & Screw System is designed for internal bone fixation, fracture stabilization, and arthrodesis—procedures where rigid alignment and secure fixation of bone fragments are critical. Its anatomically contoured plates and combination of locking and non-locking screw holes provide both compression and stability at fracture sites, ensuring proper alignment and facilitating optimal healing by minimizing movement at the surgical site.
Is the APS Metal Plate & Screw System intended for reuse, or is it meant to be used only once per patient?
The APS Metal Plate & Screw System is explicitly intended for single-use in surgical settings. This aligns with standard sterile orthopedic protocols to prevent contamination and ensure patient safety, as reuse could compromise sterility and mechanical integrity.
How should the APS Metal Plate & Screw System be stored to maintain its sterility and performance?
The system must be stored following standard sterile orthopedic protocols to preserve its integrity until surgical use. Since it is supplied sterile, it should remain in its original packaging, protected from moisture, dust, and physical damage, and kept in a clean, controlled environment as recommended for metallic orthopedic implants.
What regulatory pathway was followed for FDA clearance of the APS Metal Plate & Screw System, and what does this mean for its clinical use?
The APS Metal Plate & Screw System received FDA clearance through a 510(k) submission (K223150) under the Traditional Review pathway, determined to be substantially equivalent to predicate devices. This means it meets FDA standards for safety and effectiveness in orthopedic fixation applications, as evaluated by the Orthopedic (OR) Advisory Committee, and is approved for use in surgical settings where bone stabilization is required.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K223150