510(k) · Cleared
Recalled · Class III · 2019Juliet® Ti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 15, 2016 as substantially equivalent to K150481 (K2m, Inc., 2015) and 5 other predicates after a 210-day review. Its family tree reaches back 15 generations to 1984. 1 of the 211 devices in its family, counting itself, has a Class I recall. 75 later devices descend from it. It has been recalled once.
- Decided
- Jul 15, 2016
- Review
- 210 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 135 ancestors in all. 75 later devices descend from it, 8 citing it directly. 1 of the 211 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 1 generation backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK153621 Juliet® TiSpineart · 2016
- Descendant · cites it directly · 64 of its ownK181818 Scarlet AL-TSpineart · 2018
- Descendant · 2 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 3 generations on · 16 of its ownK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 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 backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 4 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 1 generation backK133650 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK153621 Juliet® TiSpineart · 2016
Showing 5 of 75 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 75 · See all- K181818Scarlet AL-TSpineart · 2018 · cites it directly64descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 2 generations on59descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 4 generations on28descendants
- K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on16descendants
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 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −4 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −2 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −1 | K133650 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K153621 | Juliet® Ti | Spineart | 2016 | — |
| +1 | K181818 | Scarlet AL-T | Spineart | 2018 | — |
| +2 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +3 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +4 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +3 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
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 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 9 | 0 |
| 2008 | 17 | 1 |
| 2009 | 9 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 12 | 0 |
| 2024 | 17 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 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? (6)
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 |
|---|---|---|---|
| * | K150481 | Cascadia Interbody SystemSummary page 4…II Product Code MAX CFR section 888.3080 Device panel ORTHOPEDIC Primary predicate: Cascadia Interbody System (K150481) manufactured by K2M, Inc Additional predicates: Dynamik intervertebral body fusi… | 2015 |
| * | K081888 | Dynamik Intervertebral Body Fusion DeviceSummary page 4…ed by K2M, Inc Additional predicates: Dynamik intervertebral body fusion device (renamed Legally marketed Juliet) (K081888) manufactured by Spineart; JULIET PO (K142277) manufactured predicate devices by Spineart; Capstone Control Spinal System (… | 2009 |
| * | K142277 | Juliet POSummary page 4…Additional predicates: Dynamik intervertebral body fusion device (renamed Legally marketed Juliet) (K081888) manufactured by Spineart; JULIET PO (K142277) manufactured predicate devices by Spineart; Capstone Control Spinal System (K120368) manufactured by… | 2014 |
| * | K120368 | Capstone Control Spinal SystemSummary page 4…Legally marketed Juliet) (K081888) manufactured by Spineart; JULIET PO (K142277) manufactured predicate devices by Spineart; Capstone Control Spinal System (K120368) manufactured by Medtronic Sofamor Danek Usa, In; Capstone Spinal System (K133650)… | 2012 |
| * | K133650 | Capstone Spinal SystemSummary page 4…cate devices by Spineart; Capstone Control Spinal System (K120368) manufactured by Medtronic Sofamor Danek Usa, In; Capstone Spinal System (K133650) manufactured by Medtronic Sofamor Danek Usa, In; LUCENT (K071724) manufactured b… | 2013 |
| * | K071724 | LucentSummary page 4…Medtronic Sofamor Danek Usa, In; Capstone Spinal System (K133650) manufactured by Medtronic Sofamor Danek Usa, In; LUCENT (K071724) manufactured by Spinal Elements, Inc Page 1 / 2 === Pa… | 2007 |
What descends from it? (75)
See all 758 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 5, 2019 | Class III | Z-0546-2020 | Employee error | Inner blister pack label is incorrect and does not match the correct external box label. |
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 32 years and passes through 11 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 135 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181818 (Spineart, 2018) has gone furthest, with 64 descendants of its own.
- 15 other devices also cite its predicate K150481.
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. 2016, 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?
Juliet® Ti PO, OL & TL lumbar interbody devices are 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved…
Read the full statement (135 words)
Juliet® Ti PO, OL & TL lumbar interbody devices are 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153621: Juliet® Ti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153621
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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