# K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Avalign Technologies, Inc.
- Decided: Jul 10, 2025 after 181 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 24 generations back to K841189 (1984). 460 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 462 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150673: SYNFIX Evolution Secured Spacer System, Synthes (USA) Products, LLC (2015) 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.
- 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.
- K201585: Monterey AL Interbody System, Stryker Corporation (2020) Summary page 5.

## Most influential descendants
- K252982: CONDUIT™ ZERO-P™ VA Secured Spacer System (2026), 0 descendants of its own

## Indications for use
The CONDUIT T M SYNFIXT rM Evolution Secured Spacer System is a stand-alone anterior interbody fusion device with a microscope roughened surface and micro and nano-scale features indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the CONDUIT SYNFIX Evolution can be packed with autograft. If used with less than the four integrated bone screws, or for hyperlordotic implants (>20Deg), implants must be used with supplemental fixation systems cleared by the FDA for use in the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K250072
Methodology: https://510kreport.com/methodology