510(k) Report

510(k) · Cleared

Cleared

Honour Spacer System

K120345510(k) TraditionalCleared Jun 13, 2012131-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

Nexxt Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jun 13, 2012 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 11 other predicates after a 131-day review. Its family tree reaches back 10 generations to 2001. 212 later devices descend from it.

Decided
Jun 13, 2012
Review
131 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
12

Its longest line of descent runs back 10 generations to K003155 (2001). 53 ancestors in all, the oldest K841189 (1984). 212 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 3 other ancestors2008: 4 other ancestors2006: 1 other ancestor2005: 2 other ancestors1999: 2 other ancestors2007: 3 other ancestors2004: 8 other ancestors2003: 6 other ancestors2001: 6 other ancestors1996: 2 other ancestors1984: 1 other ancestor2002: 4 other ancestors2000: 1 other ancestor2014: 5 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2019: 8 descendants cleared2020: 23 descendants cleared2017: 4 descendants cleared2018: 5 descendants cleared2021: 14 descendants cleared2016: 4 descendants cleared2022: 30 descendants cleared2023: 29 descendants cleared2024: 27 descendants cleared2026: 29 descendants cleared2025: 32 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K061836 · Avs Asl Peek Spacer System · Stryker Spine · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 11 other ancestors3 generations back: 10 other ancestors4 generations back: 9 other ancestors5 generations back: 4 other ancestors 1 generation forward: 9 descendants2 generations forward: 30 descendants3 generations forward: 48 descendants4 generations forward: 45 descendants5 generations forward: 39 descendants6 generations forward: 23 descendants7 generations forward: 13 descendants8 generations forward: 4 descendants9 generations forward: 1 descendant K061836 · Avs Asl Peek Spacer System · Stryker Spine · 2006K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · 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. · 2001−10−50+5
  1. Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 6 generations between
  3. 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  4. 2 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  5. 1 generation backK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
  6. This deviceK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
  7. Descendant · cites it directly · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
  8. Descendant · cites it directly · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  9. Descendant · 2 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
  10. Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  11. Descendant · cites it directly · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
Show all 10 generations
  1. Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations backK012254 VBROsteotech, Inc. · 2001
  3. 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 6 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 5 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 4 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 2 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 1 generation backK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
  11. This deviceK120345 Honour Spacer SystemNexxt Spine, LLC · 2012

Showing 5 of 212 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 52016: 42017: 42018: 52019: 82020: 232021: 142022: 302023: 292024: 272025: 322026: 29
2012high 32 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 212 · See all
  • K171140Matrixx SystemNexxt Spine, LLC · 2017 · cites it directly145descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · cites it directly106descendants
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 2 generations on100descendants
  • K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on99descendants
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · cites it directly93descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−9K012254VBROsteotech, Inc.2001—
−8K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−6K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−5K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−4K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−3K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−2K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−1K061836Avs Asl Peek Spacer SystemStryker Spine2006—
0 (this device)K120345Honour Spacer SystemNexxt Spine, LLC2012—
+1K171140Matrixx SystemNexxt Spine, LLC2017—
+1K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199920
200010
200160
200240
200360
200480
200520
200610
200730
200840
200930

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201450
201640
201740
201850
201980
2020230
2021140
2022300
2023290
2024270
2025320
2026290
FIG. 1 — Lineage of K120345, 2001–2026Source: 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.

Planning a device in ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (12)

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
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 2
…va®' ZA-500 PEEK) per ASTM F2026. Integral marker pins are manufactured from tantalum according to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and…
Depuy Spine, Inc.1999—
*K042571Stryker Spine Avs TL Peek Spacer
Summary page 2
…r pins are manufactured from tantalum according to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091…
Stryker Spine2005—
*K050624Stryker Spine Avs PL Peek Spacer
Summary page 2
…pins are manufactured from tantalum according to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531)…
Stryker Spine2005—
*K061836Avs Asl Peek Spacer System
Summary page 2
…pins are manufactured from tantalum according to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531)…
Stryker Spine2006—
*K062132Avs PL Peek Spacer System
Summary page 2
…are manufactured from tantalum according to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) C…
Stryker Spine2006—
*K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXX
Summary page 2
…according to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) ConstruXTM (KO051246)…
Stryker Spine2008—
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 2
…g to ASTM F560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) ConstruXTM (KO051246)…
Stryker Corp.2008—
*K083661Avs TL Peek Spacers
Summary page 2
…560. Predicate Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) ConstruXTM (KO051246) Pillar T…
Stryker Corp.2009—
*K093704Avs PL Peek Spacers
Summary page 2
…e Devices: Lumbar I/F Cage@ (P960025) AVS PEEK Spacers (K042571, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) ConstruXTM (KO051246) Pillar TM PLITL (1(08…
Stryker Corp.2009—
*K091531Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody SpacerChoice Spine, Llp2009—
*K051246Construx Mini Peek VBR System
Summary page 2
…, K050624, K061836, K062132, K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) ConstruXTM (KO051246) Pillar TM PLITL (1(081177) Technological The HONOURTM Spacer System devices possess the same Charact…
Blackstone Medical, Inc.2005—
*K081177Blackstone Medical, Inc., Pillar Spacer System
Summary page 2
…K(073470, K082014, K(083661 and K(093704) StealthTM (K(091 531) ConstruXTM (KO051246) Pillar TM PLITL (1(081177) Technological The HONOURTM Spacer System devices possess the same Characteristics: technological characteristics as t…
Blackstone Medical, Inc.2008—

Also cleared against P960025: 98 other devices →

What descends from it? (212)

See all 212

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171140Matrixx SystemNexxt Spine, LLC2017145
K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106
K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993
K133827A-Link ZOsteo Vasive, LLC201426
K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424
K122444Cervical CageEisertech, LLC201222
K133529Camber Spine Coveris Cervical CageCamber Spine201410
K131077Life Spine Plateau Spacer SystemLife Spine201310
K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201

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 11 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 5 of the 53 ancestors have a recall of any class.
  • Of its descendants, K171140 (Nexxt Spine, LLC, 2017) has gone furthest, with 145 descendants of its own.
  • 98 other devices also cite its predicate P960025.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

When used as a cervical intervertebral fusion device, the HONOUR devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is…

Read the full statement (293 words)

When used as a cervical intervertebral fusion device, the HONOUR devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).

When used as a lumbar intervertebral fusion device, the HONOUR devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).

When used as a vertebral body replacement device, the HONOUR devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).

Indications for use as stated in the FDA summary.

Also cleared against P960025

98 other devices cite the same predicate.

  • K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC · 2024
  • K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018

More from Nexxt Spine, LLC

22 FDA decisions under this applicant name. See the company

  • K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC · 2023
  • K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC · 2022
  • K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC · 2022
  • K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC · 2020
  • K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC · 2020

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K120345 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120345: Honour Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120345

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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