# K190483: SPIRA Open Matrix ALIF and LLIF

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Sep 23, 2019 after 208 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: 17 generations back to K841189 (1984). 138 ancestors in all.
9 later devices descend from it; 4 cite it directly.
1 of 148 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180724: SPIRA Open Matrix LLIF, Camber Spine Technologies, LLC (2018) Summary page 4.
- K162986: SPIRA Open Matrix ALIF, Camber Spine Technologies (2017) Summary page 4.
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015) Summary page 4.

## Most influential descendants
- 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
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own

## Indications for use
SPIRA Open Matrix ALIF 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 nonoperative 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 bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. SPIRA Open Matrix LLIF 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 nonoperative 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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K190483
Methodology: https://510kreport.com/methodology