510(k) · Cleared
Recalled · Class II · 2019Concorde Lift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 20, 2017 as substantially equivalent to K160464 (Interventional Spine, Inc., 2016) and 3 other predicates after a 66-day review. Its family tree reaches back 20 generations to 1984. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 20, 2017
- Review
- 66 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 20 generations to K841189 (1984). 159 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 2 generations backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- 1 generation backK162879 Elite Expandable Interbody Fusion DeviceSpineology, Inc. · 2017
- This deviceK171425 Concorde LiftMedos International SARL · 2017
- Descendant · cites it directly · 5 of its ownK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
- Descendant · 2 generations on · 3 of its ownK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK231680 AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK223474 PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. · 2023
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 2 generations backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- 1 generation backK162879 Elite Expandable Interbody Fusion DeviceSpineology, Inc. · 2017
- This deviceK171425 Concorde LiftMedos International SARL · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019 · cites it directly5descendants
- K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021 · 2 generations on3descendants
- K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022 · 3 generations on2descendants
- K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. · 2023 · 2 generations on1descendant
- K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −2 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion… | Spineology, Inc. | 2016 | — |
| −1 | K162879 | Elite Expandable Interbody Fusion Device | Spineology, Inc. | 2017 | — |
| 0 (this device) | K171425 | Concorde Lift | Medos International SARL | 2017 | — |
| +1 | K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2019 | — |
| +2 | K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | 2021 | — |
| +3 | K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | 2022 | — |
| +2 | K231680 | AccelFix Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2023 | — |
| +4 | K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | 2023 | — |
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 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 21 | 0 |
| 2009 | 15 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K160464 | Opticage (R) Expandable Interbody Fusion DeviceSummary page 4…and Regulation: Classification Product and Panel Code: MAX; Orthopedic D. Predicate Device Name Primary: K160464: Opticage™ Expandable Interbody Fusion Device $GGLWLRQDO: K152156: Opticage™ Expandable Interbody Fusion Device… | 2016 |
| * | K152156 | Opticage Expandable Interbody Fusion DeviceSummary page 4…MAX; Orthopedic D. Predicate Device Name Primary: K160464: Opticage™ Expandable Interbody Fusion Device $GGLWLRQDO: K152156: Opticage™ Expandable Interbody Fusion Device K113527: Opticage™ Expandable Interbody Fusion Device… | 2015 |
| * | K113527 | Opticage Interbody Fusion DeviceSummary page 4…Primary: K160464: Opticage™ Expandable Interbody Fusion Device $GGLWLRQDO: K152156: Opticage™ Expandable Interbody Fusion Device K113527: Opticage™ Expandable Interbody Fusion Device K162879: Elite™ Expandable Interbody Fusion Device (Spineology… | 2012 |
| * | K162879 | Elite Expandable Interbody Fusion DeviceSummary page 4…$GGLWLRQDO: K152156: Opticage™ Expandable Interbody Fusion Device K113527: Opticage™ Expandable Interbody Fusion Device K162879: Elite™ Expandable Interbody Fusion Device (Spineology Inc.)… | 2017 |
What descends from it? (8)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class II | Z-1225-2019 | Under Investigation by firm | A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. |
| Jul 26, 2017 | Class II | Z-0848-2018 | Under Investigation by firm | Potential for Intra-operative breakage of driver tips |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 15 of the 159 ancestors have a recall of any class.
- Of its descendants, K190708 (L&K BIOMED Co., Ltd., 2019) has gone furthest, with 5 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. 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 CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE…
Read the full statement (166 words)
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171425: Concorde Lift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171425
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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