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 Jul 16, 2010 as substantially equivalent to K081888 (Spineart, 2009) after a 28-day review. Its family tree reaches back 4 generations to 2001. 259 later devices descend from it.
- Decided
- Jul 16, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010530 (2001). 8 ancestors in all, the oldest P950002 (1996). 259 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 3 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 2 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 1 generation backK081888 Dynamik Intervertebral Body Fusion DeviceSpineart · 2009
- This deviceK101720 Juliet OLSpineart · 2010
- Descendant · cites it directly · 147 of its ownK133557 Juliet LL Lateral Lumbar CageSpineart · 2014
- Descendant · 2 generations on · 146 of its ownK141135 Juliet LLSpineart · 2014
- Descendant · 3 generations on · 145 of its ownK161888 JULIET® LL Lateral Lumbar CageSpineart · 2016
- Descendant · 4 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- Descendant · 5 generations on · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
Showing 5 of 259 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 259 · See all- K133557Juliet LL Lateral Lumbar CageSpineart · 2014 · cites it directly147descendants
- K141135Juliet LLSpineart · 2014 · 2 generations on146descendants
- K161888JULIET® LL Lateral Lumbar CageSpineart · 2016 · 3 generations on145descendants
- K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 4 generations on141descendants
- K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · 5 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −3 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −2 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −1 | K081888 | Dynamik Intervertebral Body Fusion Device | Spineart | 2009 | — |
| 0 (this device) | K101720 | Juliet OL | Spineart | 2010 | — |
| +1 | K133557 | Juliet LL Lateral Lumbar Cage | Spineart | 2014 | — |
| +2 | K141135 | Juliet LL | Spineart | 2014 | — |
| +3 | K161888 | JULIET® LL Lateral Lumbar Cage | Spineart | 2016 | — |
| +4 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
| +5 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 18 | 0 |
| 2022 | 32 | 0 |
| 2023 | 39 | 0 |
| 2024 | 42 | 0 |
| 2025 | 43 | 0 |
| 2026 | 38 | 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? (1)
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…section 21 CFR 888.3080 Device panel Orthopedic Legally marketed predicate DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE (K081888) devices manufactured by SPINEART. SPECIAL 510k JULIET OL - Extension of range of products… | 2009 |
What descends from it? (259)
See all 2598 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133557 | Juliet LL Lateral Lumbar Cage | 2014 | 147 |
| K140474 | Juliet OL | 2014 | 120 |
| K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | 2011 | 38 |
| K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 37 |
| K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 36 |
| K121567 | Oracle Lumbar Intervertebral Body Fusion Cage System | 2012 | 5 |
| K152355 | Twin Peaks Lumbar Interbody Fusion System | 2015 | 1 |
| K112696 | Twin Peaks Lumbar Cage | 2012 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K133557 (Spineart, 2014) has gone furthest, with 147 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. 2010, 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® OL 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 spondylolistesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® OL 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/K101720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101720: 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/K101720
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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