510(k) · Cleared
ClearedA-Wedge Anterior Interbody System (a-Wedge a.I.S.)
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 Sep 8, 2011 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 4 other predicates after a 135-day review. Its family tree reaches back 13 generations to 1984. 23 later devices descend from it.
- Decided
- Sep 8, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K841189 (1984). 68 ancestors in all. 23 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- This deviceK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
- Descendant · cites it directly · 21 of its ownK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- Descendant · 2 generations on · 13 of its ownK132738 Cogent Med-LifCogent Spine, LLC · 2014
- Descendant · cites it directly · 13 of its ownK133340 Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
- Descendant · 2 generations on · 12 of its ownK153123 Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 3 generations on · 12 of its ownK142193 Cogent Med-Lif XLCogent Spine, LLC · 2014
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- This deviceK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012 · cites it directly21descendants
- K132738Cogent Med-LifCogent Spine, LLC · 2014 · 2 generations on13descendants
- K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014 · cites it directly13descendants
- K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016 · 2 generations on12descendants
- K142193Cogent Med-Lif XLCogent Spine, LLC · 2014 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −1 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| 0 (this device) | 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 | — |
| +2 | K132738 | Cogent Med-Lif | Cogent Spine, LLC | 2014 | — |
| +1 | K133340 | Spineworks Anterior Lumbar Device | Spineworks, LLC | 2014 | — |
| +2 | K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2016 | — |
| +3 | K142193 | Cogent Med-Lif XL | Cogent Spine, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K071724 | LucentSummary page 1…CFR section: 21 CFR section 888.3080 Device panel: Orthopedic Legally Marketed Lucent Straight Intervertebral Body Fusion Device - K071724/ K081968 Predicate Devices: BRANTIGAN I/F CAGE - P960025 CoRent System - K071795/… | 2007 |
| * | K081968 | Modification to LucentSummary page 1…section: 21 CFR section 888.3080 Device panel: Orthopedic Legally Marketed Lucent Straight Intervertebral Body Fusion Device - K071724/ K081968 Predicate Devices: BRANTIGAN I/F CAGE - P960025 CoRent System - K071795/K100043… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…el: Orthopedic Legally Marketed Lucent Straight Intervertebral Body Fusion Device - K071724/ K081968 Predicate Devices: BRANTIGAN I/F CAGE - P960025 CoRent System - K071795/K100043 Submitter: SpineWorks, LLC… | 1999 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…ight Intervertebral Body Fusion Device - K071724/ K081968 Predicate Devices: BRANTIGAN I/F CAGE - P960025 CoRent System - K071795/K100043 Submitter: SpineWorks, LLC 16742 Gothard St., Suite 101… | 2007 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 1…ervertebral Body Fusion Device - K071724/ K081968 Predicate Devices: BRANTIGAN I/F CAGE - P960025 CoRent System - K071795/K100043 Submitter: SpineWorks, LLC 16742 Gothard St., Suite 101… | 2010 |
| † | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | 1996 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 68 ancestors have a recall of any class.
- Of its descendants, K121693 (Sapphire Medical Group, Inc., 2012) has gone furthest, with 21 descendants of its own.
- 38 other devices also cite its predicate K071724.
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. 2011, 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 A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from [2-Si. 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 (140 words)
The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from [2-Si. 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). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111166: A-Wedge Anterior Interbody System (a-Wedge a.I.S.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111166
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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