# K221324: ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Mar 30, 2023 after 328 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: 23 generations back to K841189 (1984). 389 ancestors in all.
No later device cites it as a predicate yet.
1 of 390 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173432: ENZA-A Titanium ALIF, Camber Spine Technologies (2018) Summary page 5.
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers, Camber Spine Technologies, LLC (2021) Summary page 5.

## Indications for use
The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (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 ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) must be used with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K221324
Methodology: https://510kreport.com/methodology