510(k) · Cleared
ClearedRexious Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvexel Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 8, 2017 as substantially equivalent to K111362 (Dio Medical Co., Ltd., 2011) and 1 other predicate after a 70-day review. Its family tree reaches back 9 generations to 1999. 5 later devices descend from it.
- Decided
- Dec 8, 2017
- Review
- 70 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K990745 (1999). 48 ancestors in all, the oldest K962628 (1997). 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- This deviceK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK222415 Rexious Spinal Fixation SystemDio Medical Corporation · 2022
- Descendant · cites it directly · 1 of its ownK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260362 QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal…MANTIZ Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232586 Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™…K&J Consulting Corp. · 2023
- Descendant · cites it directly · 0 of its ownK220285 PINE Pedicle Screw SystemTdm Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- This deviceK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K222415Rexious Spinal Fixation SystemDio Medical Corporation · 2022 · cites it directly1descendant
- K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021 · cites it directly1descendant
- K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd. · 2026 · 2 generations on0descendants
- K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp. · 2023 · 2 generations on0descendants
- K220285PINE Pedicle Screw SystemTdm Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −3 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −2 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −1 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| 0 (this device) | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| +1 | K222415 | Rexious Spinal Fixation System | Dio Medical Corporation | 2022 | — |
| +1 | K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021 | — |
| +2 | K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… | MANTIZ Co., Ltd. | 2026 | — |
| +2 | K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | K&J Consulting Corp. | 2023 | — |
| +1 | K220285 | PINE Pedicle Screw System | Tdm Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K111362 | Rexious Spinal Fixation SystemSummary page 5…atic and Dynamic compression bend tests per ASTM F1717 were also performed. Predicate Device: Primary predicate: Rexious Spinal Fixation System (K111362) Additional predicate: Globus Medical Inc. - CoCr rods (K100788) Performance and SE The CoCr rods and add… | 2011 |
| * | K100788 | Cocr RodsSummary page 5…performed. Predicate Device: Primary predicate: Rexious Spinal Fixation System (K111362) Additional predicate: Globus Medical Inc. - CoCr rods (K100788) Performance and SE The CoCr rods and additional Rexious implants have been demonstrated Determination: to be substantia… | 2010 |
What descends from it? (5)
3 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 18 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 48 ancestors have a recall of any class.
- Of its descendants, K222415 (Dio Medical Corporation, 2022) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K111362.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Rexious Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173131: Rexious Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173131
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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