510(k) · Cleared
ClearedRexious Hook Fixation Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Co., Ltd. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 28, 2012 as substantially equivalent to K031595 (U&I Corp., America, 2003) after a 139-day review. Its family tree reaches back 3 generations to 1988. 6 later devices descend from it.
- Decided
- Mar 28, 2012
- Review
- 139 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884263 (1988). 9 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK884263 Rogozinski Spinal SystemRichards Medical Co., Inc. · 1988
- 2 generations backK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
- 1 generation backK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
- This deviceK113324 Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK132365 Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK222415 Rexious Spinal Fixation SystemDio Medical Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK140219 Picasso II Mis Spinal SystemAccel Spine · 2014
- Descendant · 2 generations on · 0 of its ownK232586 Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™…K&J Consulting Corp. · 2023
- Descendant · 2 generations on · 0 of its ownK173185 SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013 · cites it directly2descendants
- K222415Rexious Spinal Fixation SystemDio Medical Corporation · 2022 · cites it directly1descendant
- K140219Picasso II Mis Spinal SystemAccel Spine · 2014 · 2 generations on1descendant
- K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp. · 2023 · 2 generations on0descendants
- K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884263 | Rogozinski Spinal System | Richards Medical Co., Inc. | 1988 | — |
| −2 | K983904 | Rogozinski Spinal Rod System | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| −1 | K031595 | U & I America Spinal Hook System | U&I Corp., America | 2003 | 3 |
| 0 (this device) | K113324 | Rexious Hook Fixation Systems | Dio Medical Co., Ltd. | 2012 | — |
| +1 | K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation | Accel Spine | 2013 | 2 |
| +1 | K222415 | Rexious Spinal Fixation System | Dio Medical Corporation | 2022 | — |
| +2 | K140219 | Picasso II Mis Spinal System | Accel Spine | 2014 | — |
| +2 | K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | K&J Consulting Corp. | 2023 | — |
| +2 | K173185 | SEURAT™ Universal Pedicle Screw System | Ctl Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 KWP? 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? (1)
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 |
|---|---|---|---|
| * | K031595 | U & I America Spinal Hook SystemSummary page 2…essed in this notification. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: *U&I America. Spinal Hook SystemT (K03 1595) Comparison to Predicate Devices: The Substantial equivalence of this device is based on equivalence in intended use,… | 2003 |
What descends from it? (6)
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 24 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K132365 (Accel Spine, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K031595.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113324: Rexious Hook Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113324
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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