510(k) · Cleared
ClearedFaSet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvexel Co., Ltd. · MRW System, Facet Screw Spinal Device
Cleared on Jun 28, 2018 as substantially equivalent to K131417 (Nexxt Spine, LLC, 2013) and 5 other predicates after a 100-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 28, 2018
- Review
- 100 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K994308 (2000). 11 ancestors in all, the oldest K953076 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 4 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 3 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 2 generations backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- 1 generation backK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
- This deviceK180729 FaSet Fixation SystemHuvexel Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK222515 FaSet Fixation SystemDio Medical Corporation · 2022
- Descendant · 2 generations on · 1 of its ownK232877 FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex…K&J Consulting Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
Most influential descendants
Showing 3 of 3 · See all- K222515FaSet Fixation SystemDio Medical Corporation · 2022 · cites it directly2descendants
- K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation · 2023 · 2 generations on1descendant
- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −4 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −3 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −2 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| −1 | K123932 | Zygafix Spinal Facet Screw System | X-Spine Systems, Inc. | 2013 | — |
| 0 (this device) | K180729 | FaSet Fixation System | Huvexel Co., Ltd. | 2018 | — |
| +1 | K222515 | FaSet Fixation System | Dio Medical Corporation | 2022 | — |
| +2 | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex… | K&J Consulting Corporation | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K131417 | Facet FixxSummary page 5…n bending, and Static torsion test) in accordance with the ASTM 1717 was performed. Predicate Device: Primary predicate: Nexxt Spine – Facet Fixx (K131417) Additional predicates: Globus Medical Inc. – Corridor Fixation System (K083442), Medtron… | 2013 |
| * | K083442 | Corridor Fixation SystemSummary page 5…e: Primary predicate: Nexxt Spine – Facet Fixx (K131417) Additional predicates: Globus Medical Inc. – Corridor Fixation System (K083442), Medtronic – UCSS/Townley Transfacetpedicular Screw Fixation System (K953076, K003928, K… | 2009 |
| * | K953076 | Townley Facet/Pedicular Screw Plating SystemSummary page 5…es: Globus Medical Inc. – Corridor Fixation System (K083442), Medtronic – UCSS/Townley Transfacetpedicular Screw Fixation System (K953076, K003928, K013829), and X-Spine Systems - Zygafix Spinal Facet Screw System (K123932) Pe… | 1997 |
| * | K003928 | Townley Transfacetpedicular Screw Fixation SystemSummary page 5…s Medical Inc. – Corridor Fixation System (K083442), Medtronic – UCSS/Townley Transfacetpedicular Screw Fixation System (K953076, K003928, K013829), and X-Spine Systems - Zygafix Spinal Facet Screw System (K123932) Performance… | 2001 |
| * | K013829 | Modification to Townley Transfacetpedicular Screw Fixation SystemSummary page 5…ation System (K083442), Medtronic – UCSS/Townley Transfacetpedicular Screw Fixation System (K953076, K003928, K013829), and X-Spine Systems - Zygafix Spinal Facet Screw System (K123932) Performance and The FaSet Fixation S… | 2001 |
| * | K123932 | Zygafix Spinal Facet Screw SystemSummary page 5…Transfacetpedicular Screw Fixation System (K953076, K003928, K013829), and X-Spine Systems - Zygafix Spinal Facet Screw System (K123932) Performance and The FaSet Fixation System have been demonstrated to be SE Determination: substantially equivalent to the… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222515 | FaSet Fixation System | 2022 | 2 |
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 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K222515 (Dio Medical Corporation, 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K131417.
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. 2018, 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 FaSet Screw Systems 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 FaSet Screw Systems 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 Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc 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/K180729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180729: FaSet 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/K180729
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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