510(k) · Cleared
ClearedInertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexxt Spine, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 26, 2014 as substantially equivalent to K090984 (Nexxt Spine, LLC, 2009) and 5 other predicates after a 30-day review. Its family tree reaches back 11 generations to 2001. 106 later devices descend from it.
- Decided
- Jun 26, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K003155 (2001). 119 ancestors in all, the oldest K841189 (1984). 106 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations between
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
- 1 generation backK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
- This deviceK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · cites it directly · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations backK012254 VBROsteotech, Inc. · 2001
- 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
- 1 generation backK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
- This deviceK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly100descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 4 generations on69descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −10 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −9 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −5 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K061836 | Avs Asl Peek Spacer System | Stryker Spine | 2006 | — |
| −1 | K120345 | Honour Spacer System | Nexxt Spine, LLC | 2012 | — |
| 0 (this device) | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +1 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +4 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 0 |
| 2022 | 13 | 0 |
| 2023 | 14 | 0 |
| 2024 | 17 | 0 |
| 2025 | 21 | 0 |
| 2026 | 20 | 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.
Planning a device in MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K090984 | Inertia Pedicle Screw SystemSummary page 3…iva@ ZA-500 polyetheretherketone per ASTMV F-2026 or tantalum per ASTM F-560. Predicate Devices: . Inertia® Pedicle Screw System, Nexxt Spine, K.090984, 110 1278 & 1132412 Honour m Sp~aer System, Nexxt Spine, K<120345 Facet Fixxm , Nex… | 2009 |
| * | K101278 | Inertia Pedicle Screw System | 2010 |
| * | K132412 | Inertia Mis Pedicle Screw SystemSummary page 3…polyetheretherketone per ASTMV F-2026 or tantalum per ASTM F-560. Predicate Devices: . Inertia® Pedicle Screw System, Nexxt Spine, K.090984, 110 1278 & 1132412 Honour m Sp~aer System, Nexxt Spine, K<120345 Facet Fixxm , Nexxt Spine, 1131417… | 2013 |
| * | K120345 | Honour Spacer SystemSummary page 3…ASTM F-560. Predicate Devices: . Inertia® Pedicle Screw System, Nexxt Spine, K.090984, 110 1278 & 1132412 Honour m Sp~aer System, Nexxt Spine, K<120345 Facet Fixxm , Nexxt Spine, 1131417 Struxxure Tm Anterior Cervical Plate and Screw~s… | 2012 |
| * | K131417 | Facet FixxSummary page 3…System, Nexxt Spine, K.090984, 110 1278 & 1132412 Honour m Sp~aer System, Nexxt Spine, K<120345 Facet Fixxm , Nexxt Spine, 1131417 Struxxure Tm Anterior Cervical Plate and Screw~s, Nexxt.Spin6, 1<133475 Performance Data: Performance… | 2013 |
| * | K133475 | Struxxure Anterior Cervical Plate and ScrewsSummary page 3…, Nexxt Spine, K<120345 Facet Fixxm , Nexxt Spine, 1131417 Struxxure Tm Anterior Cervical Plate and Screw~s, Nexxt.Spin6, 1<133475 Performance Data: Performance data is not provided in this submission. Technological Each spinal system implant pos… | 2013 |
What descends from it? (106)
See all 1064 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 12 of the 119 ancestors have a recall of any class.
- Of its descendants, K181435 (Alphatec Spine, Inc., 2018) has gone furthest, with 100 descendants of its own.
- 4 other devices also cite its predicate K090984.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The InertiaTM Pedlicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fuision in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (TI to S2): severe spondylolisthesis (grades 3 and 4)of the LS-S I vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture…
Read the full statement (613 words)
The InertiaTM Pedlicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fuision in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (TI to S2): severe spondylolisthesis (grades 3 and 4)of the LS-S I vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a cervical intervertebral fusion device, the HONOUR"' devices are indicated for use at one level in the cervical spine, from C2-TI, 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 I 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 intervertebrall fusion device, the HONQURTh devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S 1, 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 I 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 graft and with supplemental fixation systems cleared for Use in the lumbar spinie (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 (TI-LS) 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 thoracolurnbar spine (e.g.. the Inertia®)Pedicle Screw System).
The Facet Fixx System is intended to stabilize the spine as an aid, to fiusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translanninar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
The Facet Finx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to SI inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:
* Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
* Degenerative disease of the facets with instability
* Trauma (i.e. fracture or dislocation)
* Spondylolisthesis
* Spondlylolysis
* Pseudoarthrosis and failed previous fussion which are symptomatic or which may cause secondary instability or deformity
The Struxxurem System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion, Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with'the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141376
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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