# K230731: Zavation ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Jun 14, 2023 after 90 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: 25 generations back to K841189 (1984). 515 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 518 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170157: INDEPENDENCE® Spacers, Globus Medical, Inc. (2017) Summary page 5.
- K142271: Zavation Z-Link Lumbar, Zavation, LLC (2014) Summary page 5.
- K212811: Ti3Z Lumbar Interbody System, Zavation Medical Products, LLC (2022) Summary page 5.
- K200084: Zavation IBF System, Zavation Medical Products, LLC (2020) Summary page 5.
- K211306: Labyrinth, Zavation Medical Products, LLC (2021) Summary page 5.
- K214047: EL CAPITAN Anterior Lumbar Interbody Fusion System, Astura Medical (2022) Summary page 5.

## Most influential descendants
- K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (2024), 1 descendant of its own
- K250769: Dakota LP System (2025), 0 descendants of its own

## Indications for use
The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material. The Zavation ALIF System spacer and plate assembly are an integrated fusion device intended for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

Source page: https://510kreport.com/device/K230731
Methodology: https://510kreport.com/methodology