510(k) · Cleared
Recalled · Class II · 2023Juliet® Ti LL Lumbar Interbody Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 29, 2019 as substantially equivalent to K181818 (Spineart, 2018) and 2 other predicates after a 55-day review. Its family tree reaches back 18 generations to 1984. 1 of the 211 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- May 29, 2019
- Review
- 55 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 209 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 211 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK181818 Scarlet AL-TSpineart · 2018
- This deviceK190877 Juliet® Ti LL Lumbar Interbody DeviceSpineart · 2019
- Descendant · cites it directly · 0 of its ownK241321 Juliet® Ti LL Lumbar Interbody DeviceSpineart SA · 2024
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 5 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 4 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK181818 Scarlet AL-TSpineart · 2018
- This deviceK190877 Juliet® Ti LL Lumbar Interbody DeviceSpineart · 2019
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −5 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −2 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −1 | K181818 | Scarlet AL-T | Spineart | 2018 | — |
| 0 (this device) | K190877 | Juliet® Ti LL Lumbar Interbody Device | Spineart | 2019 | — |
| +1 | K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | 2024 | — |
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 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 19 | 0 |
| 2006 | 5 | 0 |
| 2007 | 10 | 0 |
| 2008 | 30 | 1 |
| 2009 | 14 | 0 |
| 2010 | 12 | 0 |
| 2011 | 11 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 10 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K181818 | Scarlet AL-TSummary page 4…II Product Code OVD / MAX CFR section 888.3080 Device panel ORTHOPEDIC Primary predicate: Scarlet® AL-T (K181818) manufactured by Spineart Legally marketed Additional predicates: Juliet® Ti LL (K173702) manufactured by… | 2018 |
| * | K173702 | Juliet Ti LLSummary page 4…Primary predicate: Scarlet® AL-T (K181818) manufactured by Spineart Legally marketed Additional predicates: Juliet® Ti LL (K173702) manufactured by Spineart and predicate devices Timberline® MPF (K163543) manufactured by Zimmer Biomet… | 2018 |
| * | K163543 | Biomet Fusion SystemSummary page 4…lly marketed Additional predicates: Juliet® Ti LL (K173702) manufactured by Spineart and predicate devices Timberline® MPF (K163543) manufactured by Zimmer Biomet JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241321 | Juliet® Ti LL Lumbar Interbody Device | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2023 | Class II | Z-1426-2023 | Process change control | JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay. |
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 29 of the 209 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241321 (Spineart SA, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K181818.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
JULIET® Ti LL 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 L.2-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). The JULIET® Ti LL…
Read the full statement (162 words)
JULIET® Ti LL 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 L.2-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). The JULIET® Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.
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/K190877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190877: Juliet® Ti LL Lumbar Interbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190877
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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