# K250560: BEE HA

- Pathway: 510(k) (Traditional)
- Applicant: NGMedical GmbH
- Decided: Nov 21, 2025 after 269 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 18 generations back to K003155 (2001). 245 ancestors in all.
No later device cites it as a predicate yet.
1 of 246 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203444: BEE HA Cage, NGMedical GmbH (2021) Summary page 6.
- K231371: BEE Cervical Cage, NGMedical GmbH (2024) Summary page 6.
- K173722: PATRIOT COLONIAL Spacer, SUSTAIN Spacer, Globus Medical, Inc. (2018) Summary page 6.

## Indications for use
BEE HA cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of 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 one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

Source page: https://510kreport.com/device/K250560
Methodology: https://510kreport.com/methodology