510(k) · Cleared
ClearedZygafix Spinal Facet Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MRW System, Facet Screw Spinal Device
Cleared on May 1, 2013 as substantially equivalent to K100154 (X-Spine Systems, Inc., 2010) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 2000. 18 later devices descend from it.
- Decided
- May 1, 2013
- Review
- 132 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K994308 (2000). 5 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 3 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 2 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 1 generation backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- This deviceK123932 Zygafix Spinal Facet Screw SystemX-Spine Systems, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
- Descendant · 2 generations on · 10 of its ownK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- Descendant · 3 generations on · 3 of its ownK232468 SC Medica FFXSc Medica · 2024
- Descendant · 3 generations on · 3 of its ownK240086 Ion 3DSurGenTec, LLC · 2024
- Descendant · cites it directly · 3 of its ownK180729 FaSet Fixation SystemHuvexel Co., Ltd. · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013 · cites it directly11descendants
- K211855Ion Facet Screw SystemSurGenTec, LLC · 2022 · 2 generations on10descendants
- K232468SC Medica FFXSc Medica · 2024 · 3 generations on3descendants
- K240086Ion 3DSurGenTec, LLC · 2024 · 3 generations on3descendants
- K180729FaSet Fixation SystemHuvexel Co., Ltd. · 2018 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −3 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −2 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −1 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| 0 (this device) | K123932 | Zygafix Spinal Facet Screw System | X-Spine Systems, Inc. | 2013 | — |
| +1 | K132126 | Spectrum Spine Fenestrated Facet Screw System | Spectrum Spine, LLC | 2013 | — |
| +2 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| +3 | K232468 | SC Medica FFX | Sc Medica | 2024 | — |
| +3 | K240086 | Ion 3D | SurGenTec, LLC | 2024 | — |
| +1 | K180729 | FaSet Fixation System | Huvexel Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K100154 | Fixcet Spinal Facet Screw SystemSummary page 2…*Anatomical Region *Implant Materials *Product Dimensions- *Mechanical Performance PREDICATE DEVICES *X-spine Systems, Inc. - Fixcet Spinal Facet Screw System (K100154) *SpineFrontier, Inc. - Chameleon Fixation System (K071420) PERFORMANCE DATA The implant components were tested using the foll… | 2010 |
| * | K071420 | Chameleon Fixation SystemSummary page 2…s- *Mechanical Performance PREDICATE DEVICES *X-spine Systems, Inc. - Fixcet Spinal Facet Screw System (K100154) *SpineFrontier, Inc. - Chameleon Fixation System (K071420) PERFORMANCE DATA The implant components were tested using the following standards: P… | 2008 |
What descends from it? (18)
See all 183 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 13 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K132126 (Spectrum Spine, LLC, 2013) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K100154.
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. 2013, 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 X-spine Systems, Inc. Zygafix Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (LI to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is intended for use with only autogenous bone graft material. The system is indicated for posterior surgical treatment of any or all of the following at the Li to Si (inclusive) spinal…
Read the full statement (146 words)
The X-spine Systems, Inc. Zygafix Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (LI to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is intended for use with only autogenous bone graft material. The system is indicated for posterior surgical treatment of any or all of the following at the Li to Si (inclusive) spinal levels:
* Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
" Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
*Trauma (i.e., fractures and/or dislocations),
*Spondylolisthesis,
*Spondylolysis,
*Pseudloarthrosis and/or failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123932: Zygafix Spinal Facet Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123932
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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