# K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies, LLC
- Decided: Jun 15, 2021 after 106 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: 22 generations back to K841189 (1984). 387 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 391 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device, 4Web, Inc. (2017) Summary page 5.
- K172064: Ti-Diagon Oblique TLIF, Camber Spine Technologies (2017) Summary page 5.
- K190483: SPIRA Open Matrix ALIF and LLIF, Camber Spine Technologies (2019) Summary page 5.

## Most influential descendants
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own
- K221324: ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (2023), 0 descendants of its own

## Indications for use
SPIRA®-P Posterior Lumbar Spacers are lumbar interbody fusion devices 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. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems. SPIRA®-T Oblique Posterior Lumbar Spacers are lumbar interbody fusion devices 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. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

Source page: https://510kreport.com/device/K210595
Methodology: https://510kreport.com/methodology