510(k) · Cleared
ClearedAries® Lumbar Interbodies
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 15, 2018 as substantially equivalent to K170503 (Eit Emerging Implant Technologies GmbH, 2017) and 8 other predicates after an 86-day review. Its family tree reaches back 22 generations to 1984. 1 of the 345 devices in its family, counting itself, has a Class I recall. 24 later devices descend from it.
- Decided
- Aug 15, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 22 generations to K841189 (1984). 320 ancestors in all, the oldest K792352 (1979). 24 later devices descend from it, 3 citing it directly. 1 of the 345 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 1 generation backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- This deviceK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- Descendant · cites it directly · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · cites it directly · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 2 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 2 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
- Descendant · 2 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 1 generation backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- This deviceK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 24 · See all- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · cites it directly12descendants
- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · cites it directly9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 2 generations on7descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 2 generations on5descendants
- K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −2 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −1 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| 0 (this device) | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| +1 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +1 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +2 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +2 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
| +2 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 18 | 0 |
| 2004 | 28 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 46 | 1 |
| 2009 | 26 | 0 |
| 2010 | 15 | 0 |
| 2011 | 24 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 11 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (9)
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 |
|---|---|---|---|
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 4…n 888.3080 Device Panel Orthopedic Primary Predicate x EIT Cellular Titanium® TLIF Cages, EIT Emerging Implant Technologies, GmbH Device (K170503) x CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/ K17294… | 2017 |
| * | K160547 | Cascadia Interbody SystemSummary page 4…r Titanium® TLIF Cages, EIT Emerging Implant Technologies, GmbH Device (K170503) x CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/ K172941) Secondary x BAK/L Interbody Fusion System, Zimmer (P950002) Predic… | 2016 |
| * | K162264 | Cascadia Interbody SystemSummary page 4…um® TLIF Cages, EIT Emerging Implant Technologies, GmbH Device (K170503) x CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/ K172941) Secondary x BAK/L Interbody Fusion System, Zimmer (P950002) Predicate Devi… | 2016 |
| * | K172009 | Cascadia Interbody SystemSummary page 4…Cages, EIT Emerging Implant Technologies, GmbH Device (K170503) x CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/ K172941) Secondary x BAK/L Interbody Fusion System, Zimmer (P950002) Predicate Devices x… | 2017 |
| * | K172941 | CASCADIA Interbody SystemSummary page 4…ologies, GmbH Device (K170503) x CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/ K172941) Secondary x BAK/L Interbody Fusion System, Zimmer (P950002) Predicate Devices x Oracle Cage System, Synthes (K07… | 2018 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 4…CASCADIA™ Interbody System, K2M, Incorporated (K160547/K162264/ K172009/ K172941) Secondary x BAK/L Interbody Fusion System, Zimmer (P950002) Predicate Devices x Oracle Cage System, Synthes (K072791) x ALEUTIAN® Anatomically-Narrow Oblique Inte… | 1996 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 4…4/ K172009/ K172941) Secondary x BAK/L Interbody Fusion System, Zimmer (P950002) Predicate Devices x Oracle Cage System, Synthes (K072791) x ALEUTIAN® Anatomically-Narrow Oblique Interbody System, K2M, Incorporated (K0826… | 2007 |
| * | K082698 | Aleutian Ibf SystemSummary page 4…es x Oracle Cage System, Synthes (K072791) x ALEUTIAN® Anatomically-Narrow Oblique Interbody System, K2M, Incorporated (K082698/ K101302) x Ray Threaded Lumbar Fusion Cage, Stryker (P950019) Reference Predicate x Brantigan I/F Cage,… | 2009 |
| * | K101302 | Aleutian Ibf SystemSummary page 4…Oracle Cage System, Synthes (K072791) x ALEUTIAN® Anatomically-Narrow Oblique Interbody System, K2M, Incorporated (K082698/ K101302) x Ray Threaded Lumbar Fusion Cage, Stryker (P950019) Reference Predicate x Brantigan I/F Cage, DePuy Sp… | 2010 |
| † | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | 1996 |
| † | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | 1999 |
| † | K090707 | Talos Intervertebral Body Fusion Device | 2009 |
| † | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion… | 2015 |
| † | K091088 | LDR Spine Cervical Interbody Fusion System | 2009 |
What descends from it? (24)
See all 243 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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 43 of the 320 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K213935 (Osseus Fusion Systems, 2022) has gone furthest, with 12 descendants of its own.
- 15 other devices also cite its predicate K170503.
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. 2018, 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 Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-0, Aries®-A, and Aries®-L) are interbody fusion devices intended 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 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1…
Read the full statement (118 words)
The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-0, Aries®-A, and Aries®-L) are interbody fusion devices intended 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 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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/K181347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181347: Aries® Lumbar Interbodies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181347
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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