510(k) · Cleared
ClearedRexious Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Corporation · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 25, 2022 as substantially equivalent to K173131 (Huvexel Co., Ltd., 2017) and 3 other predicates after a 76-day review. Its family tree reaches back 10 generations to 1999. 1 later device descends from it.
- Decided
- Oct 25, 2022
- Review
- 76 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K990745 (1999). 58 ancestors in all, the oldest K884263 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- This deviceK222415 Rexious Spinal Fixation SystemDio Medical Corporation · 2022
- Descendant · cites it directly · 0 of its ownK232586 Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™…K&J Consulting Corp. · 2023
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- This deviceK222415 Rexious Spinal Fixation SystemDio Medical Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −4 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −3 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −2 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −1 | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| 0 (this device) | K222415 | Rexious Spinal Fixation System | Dio Medical Corporation | 2022 | — |
| +1 | K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | K&J Consulting Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K173131 | Rexious Spinal Fixation SystemSummary page 5…d failed previous fusion. Predicate Primary predicate: Device: Huvexel Co. Ltd. - Rexious Spinal Fixation System (K173131) Additional predicates: Huvexel Co. Ltd. : Rexious Hook System (K113324)… | 2017 |
| * | K113324 | Rexious Hook Fixation SystemsSummary page 5…uvexel Co. Ltd. - Rexious Spinal Fixation System (K173131) Additional predicates: Huvexel Co. Ltd. : Rexious Hook System (K113324) Huvexel Co. Ltd. - Rexious Spinal Fixation System (K100765, K111362) Substantia… | 2012 |
| * | K100765 | Fixpine II SystemSummary page 5…dditional predicates: Huvexel Co. Ltd. : Rexious Hook System (K113324) Huvexel Co. Ltd. - Rexious Spinal Fixation System (K100765, K111362) Substantial The Rexious Spinal Fixation System is identical to the predicate Equiv… | 2010 |
| * | K111362 | Rexious Spinal Fixation SystemSummary page 5…Huvexel Co. Ltd. : Rexious Hook System (K113324) Huvexel Co. Ltd. - Rexious Spinal Fixation System (K100765, K111362) Substantial The Rexious Spinal Fixation System is identical to the predicate Equivalence: device, the Huv… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | 2023 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 58 ancestors have a recall of any class.
- Of its descendants, K232586 (K&J Consulting Corp., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K173131.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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). The Rexious Spinal…
Read the full statement (115 words)
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).
The Rexious Spinal Fixation System is intended for use as a posterior. noncervical, non-pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration ofthe disc confired by history and radiographic studies); spondylolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis: curvatures (i.e., scoliosis, kyphosis. and/or lordosis); tumor pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222415: Rexious Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222415
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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