510(k) · Cleared
ClearedInertia Pedicle Screw and Deformity Correxxion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexxt Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 26, 2016 as substantially equivalent to K152457 (Medtronic Sofamor Danek USA, Inc., 2015) and 2 other predicates after a 148-day review. Its family tree reaches back 16 generations to 1985. 17 later devices descend from it.
- Decided
- Apr 26, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K853033 (1985). 344 ancestors in all, the oldest K841189 (1984). 17 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
- Descendant · cites it directly · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 2 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 3 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
- Descendant · 3 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK223413 Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · cites it directly13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 2 generations on12descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 3 generations on5descendants
- K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 3 generations on4descendants
- K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −3 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −2 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| −1 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| 0 (this device) | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
| +1 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +2 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +3 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
| +3 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | — |
| +3 | K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 15 | 0 |
| 1999 | 21 | 0 |
| 2000 | 21 | 0 |
| 2001 | 27 | 0 |
| 2002 | 20 | 0 |
| 2003 | 21 | 0 |
| 2004 | 39 | 0 |
| 2005 | 27 | 0 |
| 2006 | 18 | 0 |
| 2007 | 15 | 0 |
| 2008 | 15 | 0 |
| 2009 | 15 | 0 |
| 2010 | 15 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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.
Planning a device in NKB? 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? (3)
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 |
|---|---|---|---|
| * | K152457 | CD HORIZON Spinal SystemSummary page 5…nium alloy (ASTM F136) and Cobalt Chrome (per ASTM F1537. Predicate Devices: Primary: CD Horizon® Spinal System (Medtronic Sofamor Danek – K152457) Additional: Tiger® Spine System (Corelink, LLC – K133369) and Inertia® Pedicle… | 2015 |
| * | K133369 | Tiger Spine SystemSummary page 5…Primary: CD Horizon® Spinal System (Medtronic Sofamor Danek – K152457) Additional: Tiger® Spine System (Corelink, LLC – K133369) and Inertia® Pedicle Screw System (Nexxt Spine – K141376) Reference Devices: Moss Miami™ Spinal S… | 2014 |
| * | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Summary page 5…K152457) Additional: Tiger® Spine System (Corelink, LLC – K133369) and Inertia® Pedicle Screw System (Nexxt Spine – K141376) Reference Devices: Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623), Synergy VLS Open (I… | 2014 |
| † | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | 2002 |
| † | K011437 | Synergy 4.0 MM, 4.5 MM VLS Screws | 2001 |
| † | K101278 | Inertia Pedicle Screw System | 2010 |
What descends from it? (17)
See all 174 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 31 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 28 of the 344 ancestors have a recall of any class.
- Of its descendants, K192121 (Osseus Fusion Systems, 2019) has gone furthest, with 13 descendants of its own.
- 7 other devices also cite its predicate K152457.
How does its category compare?
All NKB devicesNKB 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
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 Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture…
Read the full statement (135 words)
The Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Inertia® Pedicle Screw and Deformity Correxxion™ System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153453: Inertia Pedicle Screw and Deformity Correxxion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153453
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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