# K162986: SPIRA Open Matrix ALIF

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Jun 12, 2017 after 228 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: 11 generations back to K010530 (2001). 59 ancestors in all.
11 later devices descend from it; 3 cite 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)
- 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.
- K132790: Infix Anterior Lumbar System, Zimmer Spine, Inc. (2013) Summary page 4.
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE), Zimmer Spine, Inc. (2015) Summary page 4.
- K080588: Scient'x Tribeca VBR, Scient'X USA, Inc. (2008) Summary page 4.

## Most influential descendants
- K180724: SPIRA Open Matrix LLIF (2018), 10 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K162986
Methodology: https://510kreport.com/methodology