# K253894: BMD Titanium Spinal Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Global Biomedica s.r.o.
- Decided: May 28, 2026 after 175 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K841189 (1984). 362 ancestors in all.
No later device cites it as a predicate yet.
1 of 363 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage, Eit Emerging Implant Technologies GmbH (2020) Summary page 5.
- K191812: ADI Cervical Interbody Fusion Device, Additive Device, Inc. (Adi) D/B/A Restor3D (2019) Summary page 5.
- K193153: SPIRA-C Integrated Fixation System, Camber Spine Technologies (2020) Summary page 5.

## Indications for use
BMD Titanium ACIF GW implants are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The BMD Titanium ACIF GW implants are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The BMD Titanium ACIF GW implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. BMD Titanium PLIF GW, TLIF GW, ALIF, and LLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 — S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade | spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

Source page: https://510kreport.com/device/K253894
Methodology: https://510kreport.com/methodology