510(k) · Cleared
ClearedFaSet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Corporation · MRW System, Facet Screw Spinal Device
Cleared on Oct 5, 2022 as substantially equivalent to K180729 (Huvexel Co., Ltd., 2018) after a 47-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 5, 2022
- Review
- 47 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K994308 (2000). 12 ancestors in all, the oldest K953076 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 5 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 4 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 3 generations backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- 2 generations backK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
- 1 generation backK180729 FaSet Fixation SystemHuvexel Co., Ltd. · 2018
- This deviceK222515 FaSet Fixation SystemDio Medical Corporation · 2022
- Descendant · cites it directly · 1 of its ownK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −5 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −4 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −3 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| −2 | K123932 | Zygafix Spinal Facet Screw System | X-Spine Systems, Inc. | 2013 | — |
| −1 | K180729 | FaSet Fixation System | Huvexel Co., Ltd. | 2018 | — |
| 0 (this device) | K222515 | FaSet Fixation System | Dio Medical Corporation | 2022 | — |
| +1 | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex… | K&J Consulting Corporation | 2023 | — |
| +2 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 MRW? 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 MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K180729 | FaSet Fixation SystemSummary page 5…bility - Trauma including spinal fractures and/or dislocations. Predicate Primary predicate: Device: Huvexel Co. Ltd. - FaSet Fixation System (K180729) Substantial The FaSet Fixation System is identical to the predicate device and is Equivalence: as safe and effective as th… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous… | 2023 | 1 |
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 22 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K232877 (K&J Consulting Corporation, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet…
Read the full statement (178 words)
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:
- Spondylolisthesis
- Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
- Spondylolysis
- Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
- Trauma including spinal fractures and/or dislocations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222515: FaSet 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/K222515
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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