# K173432: ENZA-A Titanium ALIF

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Apr 18, 2018 after 167 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device: named in the summary without a submission number
- (no number) Camber Spine SPIRA Open Matrix ALIF Device: named in the summary without a submission number

## Most influential descendants
- K203503: Camber Sacroiliac (SI) Fixation System (2022), 2 descendants of its own
- K233972: Camber Sacroiliac (SI) Fixation System (2024), 1 descendant of its own
- K250247: panaSIa SI Fusion System (2025), 0 descendants of its own
- K221324: ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (2023), 0 descendants of its own

## Indications for use
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.

Source page: https://510kreport.com/device/K173432
Methodology: https://510kreport.com/methodology