510(k) · Cleared
ClearedENNOVATE Spinal System
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 Jul 19, 2021 as substantially equivalent to K130291 (Aesculap Implant System, Inc., 2013) and 4 other predicates after a 110-day review. Its family tree reaches back 21 generations to 1985. 1 of the 517 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 19, 2021
- Review
- 110 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 21 generations to K853033 (1985). 516 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 517 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations between
- 3 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 2 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 1 generation backK151727 Everest Spinal SystemK2m, Inc. · 2015
- This deviceK210963 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
Show all 21 generations
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 20 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 19 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 18 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 17 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 16 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 15 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 14 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 13 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 12 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 11 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 10 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 9 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 8 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 7 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 6 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 5 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 4 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 3 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 2 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 1 generation backK151727 Everest Spinal SystemK2m, Inc. · 2015
- This deviceK210963 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −20 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −19 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −18 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −17 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −16 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −15 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −14 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −13 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −12 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −11 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −10 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −9 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −8 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −7 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −6 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −5 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −4 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −3 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −2 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −1 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| 0 (this device) | 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 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 8 | 0 |
| 1998 | 18 | 0 |
| 1999 | 19 | 0 |
| 2000 | 26 | 0 |
| 2001 | 37 | 0 |
| 2002 | 30 | 0 |
| 2003 | 30 | 0 |
| 2004 | 50 | 0 |
| 2005 | 41 | 0 |
| 2006 | 30 | 0 |
| 2007 | 26 | 0 |
| 2008 | 30 | 0 |
| 2009 | 27 | 0 |
| 2010 | 26 | 1 |
| 2011 | 23 | 0 |
| 2012 | 15 | 0 |
| 2013 | 13 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K130291 | S4 Spinal SystemSummary page 4…s SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate S4 Spinal System (K130291) and Additional Predicates ENNOVATE Spinal System (K180433), Everest Spinal System (K151727), EXPEDIUM® Spinal System (K130877),… | 2013 |
| * | K180433 | Ennovate®Summary page 4…elieves that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate S4 Spinal System (K130291) and Additional Predicates ENNOVATE Spinal System (K180433), Everest Spinal System (K151727), EXPEDIUM® Spinal System (K130877), and Polaris™ Spinal System (K151974). DEVICE DESCRIPTION… | 2018 |
| * | K151727 | Everest Spinal SystemSummary page 4…System is substantially equivalent to the Primary Predicate S4 Spinal System (K130291) and Additional Predicates ENNOVATE Spinal System (K180433), Everest Spinal System (K151727), EXPEDIUM® Spinal System (K130877), and Polaris™ Spinal System (K151974). DEVICE DESCRIPTION The ENNOVATE Spinal System is an… | 2015 |
| * | K130877 | Expedium Spine SystemSummary page 4…to the Primary Predicate S4 Spinal System (K130291) and Additional Predicates ENNOVATE Spinal System (K180433), Everest Spinal System (K151727), EXPEDIUM® Spinal System (K130877), and Polaris™ Spinal System (K151974). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct spin… | 2013 |
| * | K151974 | Polaris Spinal SystemSummary page 4…tem (K130291) and Additional Predicates ENNOVATE Spinal System (K180433), Everest Spinal System (K151727), EXPEDIUM® Spinal System (K130877), and Polaris™ Spinal System (K151974). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biolog… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 36 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 53 of the 516 ancestors have a recall of any class; 1 has a Class I recall.
- 9 other devices also cite its predicate K130291.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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/K210963 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210963: ENNOVATE Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210963
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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