# K230942: SPIRA® Posterior Lumbar Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Jul 11, 2023 after 99 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 9 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers, Camber Spine Technologies, LLC (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device, 4Web, Inc. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), 4Web, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K072970: Patriot Spacers, Globus Medical, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K122097: Patriot Spacers, Globus Medical, Inc. (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers, Globus Medical, Inc. (2018). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K172941: CASCADIA Interbody System, K2m (2018). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K150206: InFill Interbody Fusion Devices, Pinnacle Spine Group, LLC (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K133721: Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif Contour Oblique and the Infill 60, Pinnacle Spine Group, LLC (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
SPIRA® Posterior Lumbar Spacers (SPIRA®-P Posterior Lumbar Spacer, SPIRA®-T Oblique Posterior Lumbar Spacer, and SPIRA®-TA Posterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation with myelopathy and/or radiculopathy, spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudoarthrosis). 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 at least six (6) months of non-operative treatment. SPIRA® Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems. SPIRA® Posterior Lumbar Spacers are intended for use with an autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone.

Source page: https://510kreport.com/device/K230942
Methodology: https://510kreport.com/methodology