# K180724: SPIRA Open Matrix LLIF

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies, LLC
- Decided: Jun 25, 2018 after 97 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 12 generations back to K010530 (2001). 60 ancestors in all.
10 later devices descend from it; 1 cites it directly.
1 of 71 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162986: SPIRA Open Matrix ALIF, Camber Spine Technologies (2017) Summary page 4.
- K083894: Alif Spinal Truss Interbody Fusion Device, 4-Web Spine, LLC (2011) Summary page 4.
- K112316: 4-Web Alif Spinal Truss System (STS), 4-Web, Inc. (2011) Summary page 4.
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 4.
- K090782: Novel Alif Spinal Spacer System, Alphatec Spine, Inc. (2009) Summary page 4.

## Most influential descendants
- K190483: SPIRA Open Matrix ALIF and LLIF (2019), 9 descendants of its own
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (2021), 3 descendants of its own
- K212980: Tesera-k ALIF System (2022), 2 descendants of its own
- K242771: Tesera-k PL System and Tesera-k XL System (2025), 1 descendant of its own
- K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (2026), 0 descendants of its own

## Indications for use
The Camber Spine Technologies SPIRA Open Matrix LLIF 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 SPIRA Open Matrix LLIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.

Source page: https://510kreport.com/device/K180724
Methodology: https://510kreport.com/methodology