510(k) Report

510(k) · Cleared

Cleared

ENNOVATE Spinal System

K162134510(k) TraditionalCleared Dec 14, 2016135-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap Implant Systems, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 14, 2016 as substantially equivalent to K130291 (Aesculap Implant System, Inc., 2013) and 18 other predicates after a 135-day review. Its family tree reaches back 18 generations to 2001. 1 of the 377 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Dec 14, 2016
Review
135 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
19

Its longest line of descent runs back 18 generations to K003155 (2001). 374 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 377 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 2 other ancestors2012: 5 other ancestors2011: 12 other ancestors2010: 17 other ancestors, 1 with a Class I recall12009: 20 other ancestors2008: 23 other ancestors2007: 16 other ancestors2004: 36 other ancestors2003: 22 other ancestors2006: 25 other ancestors2005: 33 other ancestors2002: 23 other ancestors2001: 24 other ancestors2000: 24 other ancestors1998: 17 other ancestors1997: 9 other ancestors1996: 9 other ancestors1994: 3 other ancestors1991: 1 other ancestor1999: 14 other ancestors1995: 8 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2018: 1 descendant cleared2021: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×3: 3 generations cleared close together, K040536 (2004), K041556 (2004), K043561 (2004) ×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012×3: 3 generations cleared close together, K123549 (2013), K131615 (2013), K133746 (2014) K151974 · Polaris Spinal System · Biomet Spine · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 48 other ancestors3 generations back: 97 other ancestors, 1 with a Class I recall14 generations back: 88 other ancestors5 generations back: 67 other ancestors6 generations back: 23 other ancestors7 generations back: 14 other ancestors8 generations back: 1 other ancestor9 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K151974 · Polaris Spinal System · Biomet Spine · 2015K133746 · Polaris Spinal System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalledK131615 · Polaris Spinal System · Biomet Spine (Aka Ebi, LLC) · 2013K123549 · Polaris Spinal System - Ballista II Percutaneous Screw Placement System · Biomet Spine (Aka Ebi, LLC) · 2013 · recalledK113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−15−10−50
  1. Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 14 generations between
  3. 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  4. 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  5. 1 generation backK151974 Polaris Spinal SystemBiomet Spine · 2015
  6. This deviceK162134 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  7. Descendant · cites it directly · 1 of its ownK180433 Ennovate®Aesculap Implant Systems, LLC · 2018 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK210963 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
Show all 18 generations
  1. Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 17 generations backK012254 VBROsteotech, Inc. · 2001
  3. 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 9 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 8 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 7 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 6 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 5 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 4 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  16. 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  17. 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  18. 1 generation backK151974 Polaris Spinal SystemBiomet Spine · 2015
  19. This deviceK162134 ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System3 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K180433Ennovate®Aesculap Implant Systems, LLC · 2018 · cites it directly1descendant
  • K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−17K012254VBROsteotech, Inc.2001—
−16K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−15K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−14K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−13K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−12K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−11K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−9K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−8K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−7K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−5K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
−3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
−2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
−1K151974Polaris Spinal SystemBiomet Spine2015—
0 (this device)K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC2016—
+1K180433Ennovate®Aesculap Implant Systems, LLC20181
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199110
199250
199330
199430
199580
199690
199790
1998170
1999140
2000240
2001240
2002230
2003220
2004360
2005330
2006250
2007160
2008230
2009200
2010171
2011120
201250
201320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202110
FIG. 1 — Lineage of K162134, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (19)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K130291S4 Spinal System
Summary page 4
…Orthopedics SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predi…
Aesculap Implant System, Inc.2013—
*K123939S4 Spinal System
Summary page 4
…IVALENCE Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K0902…
Aesculap Implant Systems, Inc.2013—
*K123352S4 Spinal System
Summary page 4
…Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K08294…
Aesculap Implant Systems, Inc.2012—
*K112551S4 Spinal System
Summary page 4
…Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K04111…
Aesculap Implant System, Inc.2011—
*K100623Aesculap Implant Systems S4 Spinal System
Summary page 4
…Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K07336…
Aesculap Implant Systems20101
*K090657Modification to: S4 Spinal System
Summary page 4
…LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K0…
Aesculap Implant Systems2009—
*K071945S4 Spinal System
Summary page 4
…ves that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), a…
Aesculap Implant Systems2007—
*K062085S4 Spinal System
Summary page 4
…the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polari…
Aesculap2007—
*K032219Revolution Spinal Fixation System
Summary page 4
…Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal Sys…
Spinal Innovations, Inc.2003—
*K090230Expedium Spine System
Summary page 4
…e K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DE…
Depuy Spine, Inc.2009—
*K082942Modfication to: Expedium Spine System
Summary page 4
…1 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTIO…
Depuy Spine, Inc.2008—
*K041119Expedium Spine System
Summary page 4
…al System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The EN…
Depuy Spine, Inc.2004—
*K073364Expedium 4.5MM Spine System
Summary page 4
…(including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Sp…
Depuy Spine, Inc.2008—
*K070300Expedium SFX Cross Connector System
Summary page 4
…123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Spinal System i…
Depuy Spine, Inc.20071
*K151974Polaris Spinal System
Summary page 4
…0657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct sp…
Biomet Spine2015—
*K133746Polaris Spinal System
Summary page 4
…1945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct spinal defo…
Biomet Spine (Aka Ebi, LLC)20141
*K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement System
Summary page 4
…2085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct spinal deformity and…
Biomet Spine (Aka Ebi, LLC)20132
*K0902035.5 Helical Flange Spinal System, Polaris Components
Summary page 4
…K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilita…
Ebi, L.P.2009—
*K111957Polaris Spinal System
Summary page 4
…d the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957). DEVICE DESCRIPTION The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biolog…
Biomet Spine (Ebi, LLC)2011—

Also cleared against K130291: 9 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180433Ennovate®Aesculap Implant Systems, LLC20181

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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 37 of the 374 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K180433 (Aesculap Implant Systems, LLC, 2018) has gone furthest, with 1 descendant of its own.
  • 9 other devices also cite its predicate K130291.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

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.

Also cleared against K130291

9 other devices cite the same predicate.

  • K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
  • K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
  • K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024
  • K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
  • K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
  • K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021

More from Aesculap Implant Systems, LLC

22 FDA decisions under this applicant name. See the company

  • K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC · 2022
  • K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2021
  • K180433Ennovate®Aesculap Implant Systems, LLC · 20181 recall
  • K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC · 2016
  • K153396Aesculap OrthoPilot Next GenerationAesculap Implant Systems, LLC · 2016

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K162134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162134: ENNOVATE Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162134

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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