510(k) · Cleared
ClearedSPIRA® Anterior 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 12, 2024 as substantially equivalent to K162986 (Camber Spine Technologies, 2017) and 7 other predicates after a 203-day review. Its family tree reaches back 26 generations to 1984. 4 of the 950 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 12, 2024
- Review
- 203 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 26 generations to K841189 (1984). 949 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 4 of the 950 devices in this family, counting this one, have a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 2 generations backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- 1 generation backK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- This deviceK234077 SPIRA® Anterior Lumbar SpacersCamber Spine Technologies · 2024
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 3 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 2 generations backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- 1 generation backK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- This deviceK234077 SPIRA® Anterior Lumbar SpacersCamber Spine Technologies · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −3 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −2 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| −1 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| 0 (this device) | K234077 | SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 13 | 0 |
| 1998 | 20 | 0 |
| 1999 | 24 | 0 |
| 2000 | 28 | 0 |
| 2001 | 40 | 0 |
| 2002 | 37 | 0 |
| 2003 | 42 | 0 |
| 2004 | 67 | 0 |
| 2005 | 60 | 0 |
| 2006 | 39 | 0 |
| 2007 | 34 | 0 |
| 2008 | 76 | 1 |
| 2009 | 58 | 0 |
| 2010 | 44 | 1 |
| 2011 | 59 | 0 |
| 2012 | 38 | 0 |
| 2013 | 40 | 0 |
| 2014 | 38 | 0 |
| 2015 | 39 | 1 |
| 2016 | 21 | 1 |
| 2017 | 19 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 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.
4 devices in this family have 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? (8)
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 6…A® Anterior Lumbar Spacers are substantially equivalent to the following predicate devices: Primary Predicate: Camber Spine Technologies – SPIRA® Open Matrix ALIF (K162986, K190483) Secondary Predicate: Camber Spine Technologies – SPIRA® Open Matrix LLIF (K190483) Globus Medical - HEDRON… | 2017 |
| * | K190483 | SPIRA Open Matrix ALIF and LLIFSummary page 6…or Lumbar Spacers are substantially equivalent to the following predicate devices: Primary Predicate: Camber Spine Technologies – SPIRA® Open Matrix ALIF (K162986, K190483) Secondary Predicate: Camber Spine Technologies – SPIRA® Open Matrix LLIF (K190483) Globus Medical - HEDRON IA (K2222… | 2019 |
| * | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Summary page 6…s – SPIRA® Open Matrix ALIF (K162986, K190483) Secondary Predicate: Camber Spine Technologies – SPIRA® Open Matrix LLIF (K190483) Globus Medical - HEDRON IA (K222270, K203278, K191391) 4Web - Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) CoreL… | 2022 |
| * | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Summary page 6…® Open Matrix ALIF (K162986, K190483) Secondary Predicate: Camber Spine Technologies – SPIRA® Open Matrix LLIF (K190483) Globus Medical - HEDRON IA (K222270, K203278, K191391) 4Web - Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) CoreLink, LLC… | 2021 |
| * | K191391 | HEDRON Lumbar SpacersSummary page 6…trix ALIF (K162986, K190483) Secondary Predicate: Camber Spine Technologies – SPIRA® Open Matrix LLIF (K190483) Globus Medical - HEDRON IA (K222270, K203278, K191391) 4Web - Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) CoreLink, LLC – CoreLin… | 2019 |
| * | K200002 | Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceSummary page 6…rix LLIF (K190483) Globus Medical - HEDRON IA (K222270, K203278, K191391) 4Web - Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) CoreLink, LLC – CoreLink® M3™ Stand-Alone Anterior Lumbar System (K180814) Globus Medical – CORBEL Spacers (K201087)… | 2020 |
| * | K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar SystemSummary page 6… 4Web - Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) CoreLink, LLC – CoreLink® M3™ Stand-Alone Anterior Lumbar System (K180814) Globus Medical – CORBEL Spacers (K201087) The subject SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacer is similar in d… | 2018 |
| * | K201087 | CORBEL SpacersSummary page 6…Alone (ASTS-SA) Interbody Fusion Device (K200002) CoreLink, LLC – CoreLink® M3™ Stand-Alone Anterior Lumbar System (K180814) Globus Medical – CORBEL Spacers (K201087) The subject SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacer is similar in design and identical in indications for use to th… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 113 of the 949 ancestors have a recall of any class; 4 have a Class I recall.
- 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. 2024, 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® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF, SPIRA® Open Matrix LLIF and SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc discase (DDD), disc herniation…
Read the full statement (358 words)
The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF, SPIRA® Open Matrix LLIF and SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis). spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The SPIRA® Anterior Lumbar Spacers are intended to be used with additional FDA-cleared supplemental fixation systems. The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers system must be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The Camber Spine Technologies SPIRA-A Integrated Fixation System is indicated for use at one or more levels from L1-S1 as an adjunct to fusion in skeletally mature 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 (pseudarthrosis). 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. The Camber Spine Technologies SPIRA-A Integrated Fixation System spacers must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These devices are intended to be used with or without three screws and/or anchors which accompany these implants. These spacers are intended for use with additional FDA-cleared supplemental fixation. In addition, these spacers are intended for stand-alone use in patients with DDD at one or two contiguous levels only when ≤20° lordotic implants are used with three screws per implant. Otherwise, all other configurations of this system are not intended for stand-alone use and must be used with additional FDA-cleared supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234077: SPIRA® Anterior Lumbar Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234077
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