Apollo Ankle Fracture Plating System
510(k) K213005
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213005 | Date11 Mar 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The Apollo Ankle Fracture Plating System is an orthopedic fixation device designed for internal stabilization of ankle fractures. It employs a proprietary composite material combining additive-manufactured titanium and PEEK polymer (TI-PEEK) to create ortholucent plates, enabling clear visualization of bone and joint spaces during imaging. The system includes a range of plates—such as one-third tubular, distal lateral fibula, posterior tibial, medial malleolar, hook, and syndesmosis—alongside variable-angle locking screws for secure fixation. Its design supports intraoperative and postoperative radiographic assessment without obstruction.
This system is intended for surgical use in orthopedic settings and is supplied sterile for single-use. The plates and screws are engineered to be MRI-safe, facilitating postoperative imaging without interference. The Apollo Ankle Fracture Plating System holds FDA 510(k) clearance under the Traditional review pathway, classified under product code HRS. Storage and handling follow standard sterile orthopedic implant protocols, adhering to regulatory and clinical best practices for internal fixation devices.
Other devices from Glw Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Apollo Ankle Fracture Plating System used for?
The Apollo Ankle Fracture Plating System is designed for internal stabilization of ankle fractures during surgical procedures. Its proprietary TI-PEEK (titanium-PEEK polymer) composite plates allow clear radiographic visualization of bone and joint spaces, reducing obstruction during intraoperative and postoperative imaging. This ensures accurate assessment of fracture alignment and healing progress.
How is the system supplied, and is it reusable?
The Apollo Ankle Fracture Plating System is supplied sterile and intended for single-use only. This aligns with standard sterile orthopedic implant protocols to minimize infection risks and ensure patient safety. Reuse is not recommended or supported by the manufacturer.
Are the plates and screws MRI-safe, and why does this matter?
Yes, the plates and screws in the Apollo Ankle Fracture Plating System are MRI-safe, meaning they do not interfere with magnetic resonance imaging. This is critical for postoperative monitoring, as it allows clinicians to assess bone healing and soft tissue recovery without imaging artifacts or safety concerns. The ortholucent design further enhances MRI compatibility.
What types of plates and screws are included in the system?
The system includes a variety of plates such as one-third tubular, distal lateral fibula, posterior tibial, medial malleolar, hook, and syndesmosis plates, each tailored to specific fracture patterns. These plates are paired with variable-angle locking screws to provide secure fixation and adaptability during surgery. The combination ensures stable alignment while accommodating anatomical variations.
How should the system be stored, and what precautions should be taken?
The Apollo Ankle Fracture Plating System should be stored according to standard sterile orthopedic implant protocols, which typically involve maintaining sealed, sterile packaging until use. Storage should be in a clean, dry environment protected from moisture, extreme temperatures, and physical damage. Adhering to these guidelines ensures sterility and integrity of the device prior to surgery.