# K252982: CONDUIT™ ZERO-P™ VA Secured Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Avalign Technologies, Inc.
- Decided: Jun 18, 2026 after 274 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 25 generations back to K841189 (1984). 509 ancestors in all.
No later device cites it as a predicate yet.
1 of 510 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112068: Synthes Zero-P Variable Angle (VA), Synthes Spine Co.Lp (2011) Summary page 5.
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 5.
- 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.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System, Avalign Technologies, Inc. (2025) Summary page 5.

## Indications for use
The CONDUIT ZERO-P VA Spacer is a stand-alone anterior cervical interbody fusion device with a microscopic roughened surface and micro and nano-scale features indicated for use at one or two levels of the cervical spine (C2-T1) in skeletally mature patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The interior of the spacer component should be packed with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft and implanted via an anterior approach.

Source page: https://510kreport.com/device/K252982
Methodology: https://510kreport.com/methodology