510(k) · Cleared
ClearedBlustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluestone Synergy · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 8, 2017 as substantially equivalent to K090064 (Eminent Spine, 2009) and 4 other predicates after a 74-day review. Its family tree reaches back 21 generations to 1984. 1 of the 207 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 8, 2017
- Review
- 74 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 21 generations to K841189 (1984). 204 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 207 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- This deviceK171893 Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma…Bluestone Synergy · 2017
- Descendant · cites it directly · 0 of its ownK210382 Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
- Descendant · cites it directly · 0 of its ownK203520 Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC · 2021
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- This deviceK171893 Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma…Bluestone Synergy · 2017
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −3 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −1 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| 0 (this device) | K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian)… | Bluestone Synergy | 2017 | — |
| +1 | K210382 | Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC | 2021 | — |
| +1 | K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 20 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 33 | 1 |
| 2009 | 18 | 0 |
| 2010 | 9 | 0 |
| 2011 | 15 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
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? (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 |
|---|---|---|---|
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 4…tems: Primary - Eminent Spine: Eminent Spine Interbody Fusion System (K090064) Additional - DePuy Acromed: Lumbar I/F Cage (P960025)… | 2009 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…y Fusion System (K090064) Additional - DePuy Acromed: Lumbar I/F Cage (P960025) - K2M, Inc: Aleutian System (K133614) and Cascadia System (K16… | 1999 |
| * | K133614 | Aleutian Ibf SystemSummary page 4…Additional - DePuy Acromed: Lumbar I/F Cage (P960025) - K2M, Inc: Aleutian System (K133614) and Cascadia System (K162264) - Integrity Spine: Integrity Spi… | 2014 |
| * | K162264 | Cascadia Interbody SystemSummary page 4…- DePuy Acromed: Lumbar I/F Cage (P960025) - K2M, Inc: Aleutian System (K133614) and Cascadia System (K162264) - Integrity Spine: Integrity Spine Lumbar Interbody Fusion Sys… | 2016 |
| * | K151819 | Integrity Spine Lumbar Interbody Fusion SystemSummary page 4…System (K162264) - Integrity Spine: Integrity Spine Lumbar Interbody Fusion System (K151819) K171893… | 2015 |
What descends from it? (2)
2 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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 26 of the 204 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210382 (Blustone Synergy, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 33 other devices also cite its predicate K090064.
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?
Blustone Synergy lumbar implants (Basalt, Magma, Obsidian): The Blustone Synergy lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with…
Read the full statement (237 words)
Blustone Synergy lumbar implants (Basalt, Magma, Obsidian):
The Blustone Synergy lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Blustone Synergy cervical implants (Slate):
The Blustone Synergy cervical (Slate) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171893: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171893
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