BMD Titanium Spinal Fusion System
510(k) K253894
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253894 | Date28 May 2026 | 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- Withdrawn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
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BMD Titanium Spinal Fusion System is a spinal implant designed for interbody fusion procedures, classified under orthopedic device nomenclature. Constructed from biocompatible titanium alloy (Ti64ELI), it features an internal and surface lattice structure with optimized 700µm pore size, providing structural stability and promoting osseointegration for spinal stabilization.
This system is supplied as a reusable medical device and is intended for surgical use in spinal fusion applications. It has received FDA clearance under a 510(k) submission (K253894) as substantially equivalent to a predicate device, adhering to traditional review pathways. The device is manufactured by Global Biomedica s.r.o. in Český Těšín, Czech Republic, and is categorized under product code MAX.
From the manufacturer
offers spinal surgery implants with excellent biocompatibility and bioactivity. We use the latest innovative technologies to create a line of spinal BMD Titanium Implants® made of biocompatible titanium (Ti64ELI).
Parameters and technology Global Biomedica ofers spinal surgery implants with excellent biocompatibility and bioactivity. We use the latest innovative technologies to create a line of spinal BMD Titanium Implant ®. These are implants for inter-body fusion of biocompatible titanium (Ti64ELI).
Questions
AI-generated answers, 18 Sep 2026
What materials is the BMD Titanium Spinal Fusion System made from and why does that matter for spinal fusion procedures?
The BMD Titanium Spinal Fusion System is constructed from a biocompatible titanium alloy (Ti64ELI). Titanium is widely used in spinal implants because it is lightweight, strong, and resistant to corrosion, which reduces the risk of adverse reactions in the body. The internal and surface lattice structure with optimized 700µm pore size further enhances its ability to integrate with bone (osseointegration) while maintaining structural stability during spinal fusion surgeries.
Is the BMD Titanium Spinal Fusion System intended for single-use or reusable applications, and how does this affect its use in surgery?
The BMD Titanium Spinal Fusion System is explicitly designed as a reusable medical device. This means it can be sterilized and used multiple times in surgical settings, which helps reduce costs and waste while maintaining safety standards. Reusability is common for orthopedic implants like this one, provided proper cleaning, sterilization, and maintenance protocols are followed.
What does the FDA clearance under 510(k) K253894 mean for surgeons considering this device for spinal fusion procedures?
The FDA clearance under 510(k) K253894 indicates that the BMD Titanium Spinal Fusion System has been determined to be substantially equivalent to a previously approved predicate device through the traditional review pathway. This means the FDA has reviewed its design, safety, and performance and found it comparable to existing spinal fusion implants, allowing it to be legally marketed in the U.S. for its intended surgical use.
How is the BMD Titanium Spinal Fusion System manufactured, and where can it be sourced?
The BMD Titanium Spinal Fusion System is manufactured by Global Biomedica s.r.o. in Český Těšín, Czech Republic. The facility’s address is Jablunkovská 855/48, 737 01, Český Těšín. For inquiries or sourcing, you may contact Piotr Koziel at the manufacturer’s address or through their official channels.
Does the device’s lattice structure play a specific role in spinal fusion outcomes, and if so, how?
Yes, the internal and surface lattice structure with a 700µm pore size is engineered to optimize osseointegration—the process where bone grows directly into the implant. This design promotes better bone ingrowth, stability, and long-term fusion success in spinal procedures, reducing the risk of implant loosening or failure over time.