510(k) · Cleared
ClearedSPIRA® Posterior Lumbar Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 11, 2023 after a 99-day review. The summary cites 9 numbers, none of which could be confirmed as its predicate (see the table below).
- Decided
- Jul 11, 2023
- Review
- 99 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
The summary cites 9 numbers, none of which could be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K210595 | FDA’s K210595 is SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2021 |
| Kept off the family tree | K171351 | FDA’s K171351 is Posterior Spine Truss System (PSTS) Interbody Fusion Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2017 |
| Kept off the family tree | K143258 | FDA’s K143258 is PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| Kept off the family tree | K072970 | FDA’s K072970 is Patriot Spacers Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| Kept off the family tree | K122097 | FDA’s K122097 is Patriot Spacers Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
| Kept off the family tree | K181357 | FDA’s K181357 is PATRIOT® Lumbar Spacers, SUSTAIN® Spacers Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2018 |
| Kept off the family tree | K172941 | FDA’s K172941 is CASCADIA Interbody System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2018 |
| Kept off the family tree | K150206 | FDA’s K150206 is InFill Interbody Fusion Devices Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| Kept off the family tree | K133721 | FDA’s K133721 is Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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…
Read the full statement (141 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230942: SPIRA® Posterior Lumbar Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230942
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026