510(k) · Cleared
ClearedDynamik Intervertebral Body Fusion Device
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 Feb 6, 2009 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 2 other predicates after a 219-day review. Its family tree reaches back 3 generations to 2001. 282 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 219 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010530 (2001). 7 ancestors in all, the oldest P950002 (1996). 282 later devices descend from it, 13 citing it directly.
- Root · 3 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 2 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 1 generation backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- This deviceK081888 Dynamik Intervertebral Body Fusion DeviceSpineart · 2009
- Descendant · cites it directly · 259 of its ownK101720 Juliet OLSpineart · 2010
- Descendant · cites it directly · 147 of its ownK133557 Juliet LL Lateral Lumbar CageSpineart · 2014
- Descendant · cites it directly · 146 of its ownK141135 Juliet LLSpineart · 2014
- Descendant · 2 generations on · 145 of its ownK161888 JULIET® LL Lateral Lumbar CageSpineart · 2016
- Descendant · 3 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
Showing 5 of 282 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 282 · See all- K101720Juliet OLSpineart · 2010 · cites it directly259descendants
- K133557Juliet LL Lateral Lumbar CageSpineart · 2014 · cites it directly147descendants
- K141135Juliet LLSpineart · 2014 · cites it directly146descendants
- K161888JULIET® LL Lateral Lumbar CageSpineart · 2016 · 2 generations on145descendants
- K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 3 generations on141descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −2 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −1 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| 0 (this device) | K081888 | Dynamik Intervertebral Body Fusion Device | Spineart | 2009 | — |
| +1 | K101720 | Juliet OL | Spineart | 2010 | — |
| +1 | K133557 | Juliet LL Lateral Lumbar Cage | Spineart | 2014 | — |
| +1 | K141135 | Juliet LL | Spineart | 2014 | — |
| +2 | K161888 | JULIET® LL Lateral Lumbar Cage | Spineart | 2016 | — |
| +3 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 10 | 0 |
| 2019 | 11 | 0 |
| 2020 | 12 | 0 |
| 2021 | 20 | 0 |
| 2022 | 34 | 0 |
| 2023 | 40 | 0 |
| 2024 | 42 | 0 |
| 2025 | 45 | 0 |
| 2026 | 39 | 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? (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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…ion 21 CFR 888.3080 Device panel Orthopedic LUMBAR I/F CAGE manufactured by DEPUY ACROMED Legally marketed (P960025), OPAL ORACLE SPACER (K072253) predicate devices manufactured by SYNTHES SPINE… | 1999 |
| * | K072253 | Synfix-LR SpacerSummary page 1…Orthopedic LUMBAR I/F CAGE manufactured by DEPUY ACROMED Legally marketed (P960025), OPAL ORACLE SPACER (K072253) predicate devices manufactured by SYNTHES SPINE and LUCENT Manufactured… | 2007 |
| * | K071724 | LucentSummary page 1…(K072253) predicate devices manufactured by SYNTHES SPINE and LUCENT Manufactured by SPINAL ELEMENTS INC (K071724) DYNAMIK range of products consists of lumbar Interbody ca… | 2007 |
What descends from it? (282)
See all 28213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101720 | Juliet OL | 2010 | 259 |
| K133557 | Juliet LL Lateral Lumbar Cage | 2014 | 147 |
| K141135 | Juliet LL | 2014 | 146 |
| K140474 | Juliet OL | 2014 | 120 |
| K142277 | Juliet PO | 2014 | 119 |
| K153621 | Juliet® Ti | 2016 | 75 |
| 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 |
| K120024 | Mectalif Transforaminal | 2012 | 23 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K101720 (Spineart, 2010) has gone furthest, with 259 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2009, 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?
DYNAMIK 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 I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. DYNAMIK 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/K081888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081888: Dynamik Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081888
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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