# K153720: ENZA Zero-Profile Anterior Interbody Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: May 3, 2016 after 127 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: 13 generations back to K841189 (1984). 56 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110327: LDR Spine Roi-a Interbody Fusion System, Ldr Spine USA (2011) Summary page 4.
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 4.

## Most influential descendants
- K180963: Roccia Alif, Roccia Tlif (2018), 3 descendants of its own
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- K221172: FOCUS Interbody System (2022), 0 descendants of its own
- K190680: Favo S-Tlif (2019), 0 descendants of its own

## Indications for use
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).

Source page: https://510kreport.com/device/K153720
Methodology: https://510kreport.com/methodology