510(k) · Cleared
ClearedSpineworks Anterior Lumbar Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineworks, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 11, 2014 as substantially equivalent to K111166 (Spineworks, LLC, 2011) and 2 other predicates after a 163-day review. Its family tree reaches back 15 generations to 1984. 13 later devices descend from it.
- Decided
- Apr 11, 2014
- Review
- 163 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 81 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
- 1 generation backK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- This deviceK133340 Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
- Descendant · cites it directly · 12 of its ownK153123 Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 2 generations on · 11 of its ownK161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 2 generations on · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 3 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 4 generations on · 3 of its ownK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
- 1 generation backK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- This deviceK133340 Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016 · cites it directly12descendants
- K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016 · 2 generations on11descendants
- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · 2 generations on9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 3 generations on7descendants
- K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −2 | K111166 | A-Wedge Anterior Interbody System (a-Wedge a.I.S.) | Spineworks, LLC | 2011 | — |
| −1 | K121693 | A-Wedge Anterior Interbody System (a-Wedge Ais) | Sapphire Medical Group, Inc. | 2012 | — |
| 0 (this device) | K133340 | Spineworks Anterior Lumbar Device | Spineworks, LLC | 2014 | — |
| +1 | K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2016 | — |
| +2 | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Genesys Spine | 2016 | — |
| +2 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +3 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +4 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | — |
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 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
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? (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 |
|---|---|---|---|
| * | K111166 | A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Summary page 1…sion device - lumbar Classification Code: MAX - Class 11 Classification Panel: Orthopedic Regulation Number: 21 CFR section 888.3080 C. PREDICATE DEVICES K111166 SpineWorks A-Wedge Anterior Interbody System; manufactured by SpineWorks, LLC K121693… | 2011 |
| * | K121693 | A-Wedge Anterior Interbody System (a-Wedge Ais)Summary page 1…section 888.3080 C. PREDICATE DEVICES K111166 SpineWorks A-Wedge Anterior Interbody System; manufactured by SpineWorks, LLC K121693 A-Wedge Anterior Interbody System manufactured by Sapphire Medical Group, LLC K123969… | 2012 |
| * | K123969 | XiphosSummary page 1…SpineWorks, LLC K121693 A-Wedge Anterior Interbody System manufactured by Sapphire Medical Group, LLC K123969 The XIPHOSTM ALIF manufactured by Diffusion Technologies Spine Works, LLC… | 2013 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153123 | Genesys Spine Apache Interbody Fusion System | 2016 | 12 |
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.
What does this lineage say?
- The line of descent spans 30 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 81 ancestors have a recall of any class.
- Of its descendants, K153123 (Genesys Spine, 2016) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K111166.
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. 2014, 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 SpineWorks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved…
Read the full statement (134 words)
The SpineWorks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SpineWorks Anterior Lumbar Devices are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SpineWorks Anterior Lumbar Devices are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133340: Spineworks Anterior Lumbar Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133340
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