510(k) Report

510(k) · Cleared

Cleared

Stable-C Interbody System

K181621510(k) TraditionalCleared Oct 19, 2018121-day reviewClass II21 CFR 888.3080

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

Nexus Spine, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Oct 19, 2018 as substantially equivalent to K170297 (Nexus Spine, LLC, 2017) and 17 other predicates after a 121-day review. Its family tree reaches back 21 generations to 1984. 1 of the 342 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.

Decided
Oct 19, 2018
Review
121 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
18

Its longest line of descent runs back 21 generations to K841189 (1984). 334 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 1 citing it directly. 1 of the 342 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2018: 2 other ancestors2017: 4 other ancestors2016: 7 other ancestors2015: 9 other ancestors2014: 20 other ancestors2012: 15 other ancestors2011: 27 other ancestors2008: 44 other ancestors, 1 with a Class I recall12007: 17 other ancestors2013: 16 other ancestors2010: 18 other ancestors2009: 27 other ancestors2002: 10 other ancestors2001: 11 other ancestors2005: 15 other ancestors2004: 25 other ancestors2003: 14 other ancestors1999: 6 other ancestors1996: 2 other ancestors2006: 12 other ancestors2000: 4 other ancestors1998: 3 other ancestors1995: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2023: 2 descendants cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K072120 (2007), K073291 (2008) K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×2: 2 generations cleared close together, K141217 (2014), K143163 (2015) ×3: 3 generations cleared close together, K153782 (2016), K160916 (2016), K162138 (2016) K170961 · NuVasive CoRoent Small Interlock II System · Nu Vasive, Incorporated · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 30 other ancestors3 generations back: 38 other ancestors4 generations back: 53 other ancestors5 generations back: 51 other ancestors, 1 with a Class I recall16 generations back: 51 other ancestors7 generations back: 46 other ancestors8 generations back: 20 other ancestors9 generations back: 6 other ancestors10 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants K170961 · NuVasive CoRoent Small Interlock II System · Nu Vasive, Incorporated · 2017K162138 · NuVasive CoRoent Small Ti-C System · Nu Vasive, Incorporated · 2016K160916 · CoRoent® Ti-C System · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−20−15−10−50
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 17 generations between
  3. 3 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
  4. 2 generations backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
  5. 1 generation backK170961 NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated · 2017
  6. This deviceK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
  7. Descendant · cites it directly · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
  8. Descendant · 2 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
  9. Descendant · 3 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
  10. Descendant · 2 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
  11. Descendant · 3 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
Show all 21 generations
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 3 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
  20. 2 generations backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
  21. 1 generation backK170961 NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated · 2017
  22. This deviceK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2023: 22024: 32025: 12026: 1
2023high 3 (2024) · low 1 (2025)2026

Class I recalls in this family

  • K073202 Ardis Spacer5 generations back · 2008

Most influential descendants

Showing 5 of 7 · See all
  • K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · cites it directly6descendants
  • K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on5descendants
  • K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on3descendants
  • K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on2descendants
  • K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−20K990148Stackable Cage SystemDepuy Motech Acromed1999—
−19K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−18K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−17K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−16K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−15K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−14K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−13K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−12K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−11K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−10K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−9K121683Acculif TL CageCoalign Innovations, Inc.2012—
−8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−7K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−6K141217Acculif TL and PL CageStryker Corporation20143
−5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−3K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016—
−2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016—
−1K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated2017—
0 (this device)K181621Stable-C Interbody SystemNexus Spine, LLC2018—
+1K231763Stable-C Interbody SystemNexus Spine, LLC2023—
+2K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC2023—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC2024—
+2K241467Stable-C Interbody SystemNexus Spine, LLC2024—
+3K261279DeltaNEC Interbody SystemNexus Spine2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199210
199310
199510
199620
199830
199960
200040
2001110
2002100
2003140
2004250
2005150
2006120
2007170
2008441
2009270
2010180
2011270
2012150
2013160
2014200
201590
201670
201740
201820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
202430
202510
202610
FIG. 1 — Lineage of K181621, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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? (18)

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
*K170297Tranquil Interbody System
Summary page 4
…e: OVE, ODP Predicate Devices The subject Stable-C Interbody System is substantially equivalent to multiple predicate devices. The Nexus Spine Tranquil (K170297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K1507…
Nexus Spine, LLC2017—
*K181295Genesys Spine AIS-C Cervical Stand-Alone System
Cleared while this submission was under review
Summary page 4
…ially equivalent to multiple predicate devices. The Nexus Spine Tranquil (K170297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-…
Genesys Spine2018—
*K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants
Summary page 4
…e predicate devices. The Nexus Spine Tranquil (K170297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K14207…
Ldr Spine USA, Inc.2011—
*K150765LDR Spine ROI-C Cervical Cage System
Summary page 4
…te devices. The Nexus Spine Tranquil (K170297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K15005…
Ldr Spine USA2015—
*K151934ROI-C Titanium-Coated Implant System
Summary page 4
…s. The Nexus Spine Tranquil (K170297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryk…
Ldr Spine USA2015—
*K171489Acapella Cervical Spacer System
Summary page 4
…297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spin…
Choicespine, LP2017—
*K122008Incite Anchored Cervical Interbody (Aci) Fusion Device
Summary page 4
…predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K1332…
Incite Innovation, LLC2012—
*K072415Stalif (TM) C
Summary page 4
…lude the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K1…
Surgicraft, Ltd.2008—
*K120819Stalif C
Summary page 4
…Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), N…
Centinel Spine, Inc.2012—
*K142079Stalif Cti, Stalif C
Summary page 4
…pine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive C…
Centinel Spine, Inc.2014—
*K150053STALIF C; STALIF C-Ti
Summary page 4
…C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Sm…
Centinel Spine, Inc.2015—
*K102606Avs Anchor-C Cervical Cage System
Summary page 4
…559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and th…
Stryker Spine20111
*K133218Crystal ®; Mosaic ®; Vertu ®
Summary page 4
…Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Dev…
Spinal Elements, Inc.2014—
*K071833Mosaic Devices
Summary page 4
…(K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Device (K103…
Spinal Elements, Inc.2007—
*K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Summary page 4
…K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Device (K103033, K111119). Device Descri…
Renovis Surgical Technologies2016—
*K170961NuVasive CoRoent Small Interlock II System
Summary page 4
…0819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Device (K103033, K111119). Device Description The Stable-C Interbody System is an anter…
Nu Vasive, Incorporated2017—
*K103033Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx
Summary page 4
…, Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Device (K103033, K111119). Device Description The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordot…
Zimmer Trabecular Metal Technology2011—
*K111119Trabecular Metal (TM) Fusion Device
Summary page 4
…Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Device (K103033, K111119). Device Description The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles…
Zimmer Spine, Inc.2011—

Also cleared against K170297: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K231763Stable-C Interbody SystemNexus Spine, LLC20236

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.

  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 34 years and passes through 13 companies; a new generation was cleared every 10 months on median.
  • 39 of the 334 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K231763 (Nexus Spine, LLC, 2023) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K170297.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

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

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, 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
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine.…

Read the full statement (110 words)

The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K170297

5 other devices cite the same predicate.

  • K233375Tranquil-L Interbody SystemNexus Spine, LLC · 2024
  • K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024
  • K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
  • K181702Tranquil-L Interbody SystemNexus Spine, LLC · 2018
  • K181483Tranquil Interbody SystemNexus Spine, LLC · 2018

More from Nexus Spine, LLC

17 FDA decisions under this applicant name. See the company

  • K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025
  • K241467Stable-C Interbody SystemNexus Spine, LLC · 2024
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https://510kreport.com/device/K181621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181621: Stable-C Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181621

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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