510(k) · Cleared
ClearedSPIRA Open Matrix LLIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 25, 2018 as substantially equivalent to K162986 (Camber Spine Technologies, 2017) and 4 other predicates after a 97-day review. Its family tree reaches back 12 generations to 2001. 1 of the 71 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Jun 25, 2018
- Review
- 97 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K010530 (2001). 60 ancestors in all, the oldest P950002 (1996). 10 later devices descend from it, 1 citing it directly. 1 of the 71 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 8 generations between
- 3 generations backK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- 2 generations backK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- 1 generation backK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
- This deviceK180724 SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
- Descendant · cites it directly · 9 of its ownK190483 SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019
- Descendant · 2 generations on · 3 of its ownK210595 SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar…Camber Spine Technologies, LLC · 2021
- Descendant · 2 generations on · 2 of its ownK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL…Kyocera Medical Technologies, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 11 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 10 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 9 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 8 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 7 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 6 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- 5 generations backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- 4 generations backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- 3 generations backK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- 2 generations backK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- 1 generation backK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
- This deviceK180724 SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 10 · See all- K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019 · cites it directly9descendants
- K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC · 2021 · 2 generations on3descendants
- K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022 · 2 generations on2descendants
- K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025 · 3 generations on1descendant
- K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −11 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −10 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −9 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −8 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −7 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −6 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| −5 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| −4 | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx | Zimmer Trabecular Metal Technology | 2011 | — |
| −3 | K133784 | Vista-S Device, Associated Instrumentation | Zimmer Trabecular Metal Technology | 2014 | — |
| −2 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical… | Zimmer Spine, Inc. | 2015 | — |
| −1 | K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017 | — |
| 0 (this device) | K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC | 2018 | — |
| +1 | K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019 | — |
| +2 | K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | 2021 | — |
| +2 | K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +3 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +3 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System… | Kyocera Medical Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 1 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162986 | SPIRA Open Matrix ALIFSummary page 4…CFR §888.3080, Intervertebral body fusion device Class: II Product Codes: MAX Primary Predicate: SPIRA Open Matrix ALIF (K162986) Additional Predicate(s): 4WEB Medical LATERAL Spinal Truss System (K083894,K112316), Alphatec… | 2017 |
| * | K083894 | Alif Spinal Truss Interbody Fusion DeviceSummary page 4…MAX Primary Predicate: SPIRA Open Matrix ALIF (K162986) Additional Predicate(s): 4WEB Medical LATERAL Spinal Truss System (K083894,K112316), Alphatec Spine Novel (K080699, K090782), and Camber Spine SPIRA Open Matric ALIF (K162986)… | 2011 |
| * | K112316 | 4-Web Alif Spinal Truss System (STS)Summary page 4…imary Predicate: SPIRA Open Matrix ALIF (K162986) Additional Predicate(s): 4WEB Medical LATERAL Spinal Truss System (K083894,K112316), Alphatec Spine Novel (K080699, K090782), and Camber Spine SPIRA Open Matric ALIF (K162986). Indic… | 2011 |
| * | K080699 | Novel Spinal Spacer SystemSummary page 4…Open Matrix ALIF (K162986) Additional Predicate(s): 4WEB Medical LATERAL Spinal Truss System (K083894,K112316), Alphatec Spine Novel (K080699, K090782), and Camber Spine SPIRA Open Matric ALIF (K162986). Indications For Use: The Camber Spine… | 2008 |
| * | K090782 | Novel Alif Spinal Spacer SystemSummary page 4…rix ALIF (K162986) Additional Predicate(s): 4WEB Medical LATERAL Spinal Truss System (K083894,K112316), Alphatec Spine Novel (K080699, K090782), and Camber Spine SPIRA Open Matric ALIF (K162986). Indications For Use: The Camber Spine Technolo… | 2009 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190483 | SPIRA Open Matrix ALIF and LLIF | 2019 | 9 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 7 of the 60 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190483 (Camber Spine Technologies, 2019) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K162986.
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. 2018, 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?
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 non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I…
Read the full statement (116 words)
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 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 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 material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180724: SPIRA Open Matrix LLIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180724
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026