510(k) · Cleared
Recalled · Class II · 2022Ennovate®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 26, 2018 as substantially equivalent to K162134 (Aesculap Implant Systems, LLC, 2016) after a 65-day review. Its family tree reaches back 19 generations to 2001. 1 of the 377 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 26, 2018
- Review
- 65 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 19 generations to K003155 (2001). 375 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 377 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations between
- 3 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 2 generations backK151974 Polaris Spinal SystemBiomet Spine · 2015
- 1 generation backK162134 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
- This deviceK180433 Ennovate®Aesculap Implant Systems, LLC · 2018
- Descendant · cites it directly · 0 of its ownK210963 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
Show all 19 generations
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 18 generations backK012254 VBROsteotech, Inc. · 2001
- 17 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 14 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 9 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 7 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 5 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 4 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 3 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 2 generations backK151974 Polaris Spinal SystemBiomet Spine · 2015
- 1 generation backK162134 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
- This deviceK180433 Ennovate®Aesculap Implant Systems, LLC · 2018
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −18 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −17 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −14 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −9 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −7 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −5 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −4 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −2 | K151974 | Polaris Spinal System | Biomet Spine | 2015 | — |
| −1 | K162134 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2016 | — |
| 0 (this device) | K180433 | Ennovate® | Aesculap Implant Systems, LLC | 2018 | — |
| +1 | K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 17 | 0 |
| 1999 | 14 | 0 |
| 2000 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 23 | 0 |
| 2003 | 22 | 0 |
| 2004 | 36 | 0 |
| 2005 | 33 | 0 |
| 2006 | 25 | 0 |
| 2007 | 16 | 0 |
| 2008 | 23 | 0 |
| 2009 | 20 | 0 |
| 2010 | 17 | 1 |
| 2011 | 12 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K162134 | ENNOVATE Spinal SystemSummary page 4…Orthopedics SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K162134 – Aesculap ENNOVATE Spinal System and the Reference Predicates K130291, K062085 and K071945 – Aesculap S4 Spinal System. DEVICE… | 2016 |
| † | K130291 | S4 Spinal System | 2013 |
| † | K062085 | S4 Spinal System | 2007 |
| † | K071945 | S4 Spinal System | 2007 |
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 |
|---|---|---|---|
| K210963 | ENNOVATE Spinal System | 2021 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2022 | Class II | Z-1638-2022 | Under Investigation by firm | Potential for the incorrect screw to be included in the package. |
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 37 of the 375 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210963 (Aesculap Implant Systems, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities. 1.…
Read the full statement (116 words)
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.
1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis,
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor,
7. Pseudoarthrosis, and
8. Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180433: Ennovate®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180433
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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