510(k) · Cleared
ClearedSPIRA Open Matrix ALIF
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 Jun 12, 2017 as substantially equivalent to K083894 (4-Web Spine, LLC, 2011) and 6 other predicates after a 228-day review. Its family tree reaches back 11 generations to 2001. 1 of the 71 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Jun 12, 2017
- Review
- 228 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K010530 (2001). 59 ancestors in all, the oldest P950002 (1996). 11 later devices descend from it, 3 citing it directly. 1 of the 71 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 7 generations between
- 3 generations backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- 2 generations backK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- 1 generation backK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- This deviceK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
- Descendant · cites it directly · 10 of its ownK180724 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
Show all 11 generations
- Root · 11 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 10 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 9 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 8 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 7 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 6 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 5 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- 4 generations backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- 3 generations backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- 2 generations backK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- 1 generation backK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- This deviceK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 11 · See all- K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −10 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −9 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −8 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −7 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −6 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −5 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| −4 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| −3 | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx | Zimmer Trabecular Metal Technology | 2011 | — |
| −2 | K133784 | Vista-S Device, Associated Instrumentation | Zimmer Trabecular Metal Technology | 2014 | — |
| −1 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical… | Zimmer Spine, Inc. | 2015 | — |
| 0 (this device) | K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K083894 | Alif Spinal Truss Interbody Fusion DeviceSummary page 4…0, Intervertebral body fusion device Class: II Product Codes: MAX Primary Predicate: 4WEB Medical ALIF Spinal Truss System (K083894, K112316) Additional Predicate(s): Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix… | 2011 |
| * | K112316 | 4-Web Alif Spinal Truss System (STS)Summary page 4…Class: II Product Codes: MAX Primary Predicate: 4WEB Medical ALIF Spinal Truss System (K083894, K112316) Additional Predicate(s): Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lu… | 2011 |
| * | K080699 | Novel Spinal Spacer SystemSummary page 4…MAX Primary Predicate: 4WEB Medical ALIF Spinal Truss System (K083894, K112316) Additional Predicate(s): Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient’x… | 2008 |
| * | K090782 | Novel Alif Spinal Spacer SystemSummary page 4…mary Predicate: 4WEB Medical ALIF Spinal Truss System (K083894, K112316) Additional Predicate(s): Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient’x… | 2009 |
| * | K132790 | Infix Anterior Lumbar SystemSummary page 4…K112316) Additional Predicate(s): Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient’x Tribeca Cage (K080588). Indications For Use: The Camber Spine Technologies S… | 2013 |
| * | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Summary page 4…K112316) Additional Predicate(s): Alphatec Spine Novel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient’x Tribeca Cage (K080588). Indications For Use: The Camber Spine Technologies SPIRA Open… | 2015 |
| * | K080588 | Scient'x Tribeca VBRSummary page 4…ovel (K080699, K090782), Zimmer Spine InFix Anterior Lumbar System (K132790, K143297), and Scient’x Tribeca Cage (K080588). Indications For Use: The Camber Spine Technologies SPIRA Open Matrix ALIF is indicated for use in skeletally mature patients w… | 2008 |
What descends from it? (11)
See all 113 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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 9 companies; a new generation was cleared every 7 months on median.
- 7 of the 59 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180724 (Camber Spine Technologies, LLC, 2018) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K083894.
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. 2017, 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 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 non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade…
Read the full statement (115 words)
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 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 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 graft material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162986: SPIRA Open Matrix ALIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162986
Report an extraction error
Are you the manufacturer?
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