510(k) · Cleared
ClearedJuliet OL
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 Apr 18, 2014 as substantially equivalent to K081888 (Spineart, 2009) and 4 other predicates after a 52-day review. Its family tree reaches back 13 generations to 1984. 120 later devices descend from it.
- Decided
- Apr 18, 2014
- Review
- 52 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K841189 (1984). 70 ancestors in all. 120 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK140474 Juliet OLSpineart · 2014
- Descendant · cites it directly · 119 of its ownK142277 Juliet POSpineart · 2014
- Descendant · 2 generations on · 75 of its ownK153621 Juliet® TiSpineart · 2016 · Recalled
- Descendant · 3 generations on · 64 of its ownK181818 Scarlet AL-TSpineart · 2018
- Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 2 generations on · 59 of its ownK172816 TiGer Shark™ SystemChoicespine, LP · 2018
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 backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK140474 Juliet OLSpineart · 2014
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K142277Juliet POSpineart · 2014 · cites it directly119descendants
- K153621Juliet® TiSpineart · 2016 · 2 generations on75descendants
- K181818Scarlet AL-TSpineart · 2018 · 3 generations on64descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
- K172816TiGer Shark™ SystemChoicespine, LP · 2018 · 2 generations on59descendants
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 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −2 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −1 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| 0 (this device) | K140474 | Juliet OL | Spineart | 2014 | — |
| +1 | K142277 | Juliet PO | Spineart | 2014 | — |
| +2 | K153621 | Juliet® Ti | Spineart | 2016 | 1 |
| +3 | K181818 | Scarlet AL-T | Spineart | 2018 | — |
| +4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +2 | K172816 | TiGer Shark™ System | Choicespine, LP | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 13 | 0 |
| 2023 | 16 | 0 |
| 2024 | 25 | 0 |
| 2025 | 23 | 0 |
| 2026 | 21 | 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 |
|---|---|---|---|
| * | K081888 | Dynamik Intervertebral Body Fusion DeviceSummary page 1…MAX CFR section 888.3080 Device panel ORTHOPEDIC JULIET® lumbar cages (K081888 and K101720) manufactured by Legally rnarketed' Spineart; Capstone (K(121760, K(120368) manufactured by Medtron… | 2009 |
| * | K101720 | Juliet OLSummary page 1…MAX CFR section 888.3080 Device panel ORTHOPEDIC JULIET® lumbar cages (K081888 and K101720) manufactured by Legally rnarketed' Spineart; Capstone (K(121760, K(120368) manufactured by Medtronic; predica… | 2010 |
| * | K121760 | Capstone Spinal SystemSummary page 1…ORTHOPEDIC JULIET® lumbar cages (K081888 and K101720) manufactured by Legally rnarketed' Spineart; Capstone (K(121760, K(120368) manufactured by Medtronic; predicate devices. AVS PL PEEK AVS Plus -UniLIF (K(090816) manufactured b… | 2012 |
| * | K120368 | Capstone Control Spinal SystemSummary page 1…EDIC JULIET® lumbar cages (K081888 and K101720) manufactured by Legally rnarketed' Spineart; Capstone (K(121760, K(120368) manufactured by Medtronic; predicate devices. AVS PL PEEK AVS Plus -UniLIF (K(090816) manufactured by Stryker… | 2012 |
| * | K090816 | Stryker Spine Avs PL Peek SpacersSummary page 1…gally rnarketed' Spineart; Capstone (K(121760, K(120368) manufactured by Medtronic; predicate devices. AVS PL PEEK AVS Plus -UniLIF (K(090816) manufactured by Stryker ____ ___ ___ ___ Spine JULIET®9 Lumbar Interbod… | 2009 |
What descends from it? (120)
See all 1201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142277 | Juliet PO | 2014 | 119 |
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 30 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 70 ancestors have a recall of any class.
- Of its descendants, K142277 (Spineart, 2014) has gone furthest, with 119 descendants of its own.
- 12 other devices also cite its predicate K081888.
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. 2014, 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® Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) 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). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. 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/K140474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140474: Juliet OL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140474
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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