510(k) · Cleared
ClearedSPIRA Open Matrix ALIF and LLIF
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 Sep 23, 2019 as substantially equivalent to K180724 (Camber Spine Technologies, LLC, 2018) and 2 other predicates after a 208-day review. Its family tree reaches back 17 generations to 1984. 1 of the 148 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Sep 23, 2019
- Review
- 208 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K841189 (1984). 138 ancestors in all. 9 later devices descend from it, 4 citing it directly. 1 of the 148 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- This deviceK190483 SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019
- Descendant · cites it directly · 3 of its ownK210595 SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar…Camber Spine Technologies, LLC · 2021
- Descendant · cites it directly · 2 of its ownK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL…Kyocera Medical Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 4 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- This deviceK190483 SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019
Showing 5 of 9 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 9 · See all- K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC · 2021 · cites it directly3descendants
- K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022 · cites it directly2descendants
- K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025 · 2 generations on1descendant
- K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc. · 2026 · 2 generations on0descendants
- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −4 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −3 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −1 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| 0 (this device) | K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019 | — |
| +1 | K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | 2021 | — |
| +1 | K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +2 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +2 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System… | Kyocera Medical Technologies, Inc. | 2026 | — |
| +2 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 13 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 17 | 1 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K180724 | SPIRA Open Matrix LLIFSummary page 4…888.3080 Regulatory Class: Class II Product codes MAX III. PREDICATE DEVICES Primary Predicates: SPIRA Open Matrix LLIF (K180724) SPIRA Open Matrix ALIF (K162986) Additional Predicate: Centinel Spine STALIF TT70, ST… | 2018 |
| * | K162986 | SPIRA Open Matrix ALIFSummary page 4…MAX III. PREDICATE DEVICES Primary Predicates: SPIRA Open Matrix LLIF (K180724) SPIRA Open Matrix ALIF (K162986) Additional Predicate: Centinel Spine STALIF TT70, STALIF MIDLINE®, MIDLINE II™, and M… | 2017 |
| * | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiSummary page 4…Open Matrix ALIF (K162986) Additional Predicate: Centinel Spine STALIF TT70, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ (K150643) Reference Predicate: SPIRA-C Open Matrix Cervical Interbody, Camber Spine Technologi… | 2015 |
| † | K172446 | SPIRA-C Open Matrix Cervical Interbody | 2017 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 35 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 20 of the 138 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210595 (Camber Spine Technologies, LLC, 2021) has gone furthest, with 3 descendants of its own.
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. 2019, 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 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…
Read the full statement (260 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190483: SPIRA Open Matrix ALIF and LLIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190483
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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