510(k) · Cleared
ClearedZyfuse Facet Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Jul 14, 2009 as substantially equivalent to K083442 (Globus Medical, Inc., 2009) after a 102-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Jul 14, 2009
- Review
- 102 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083442 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK083442 Corridor Fixation SystemGlobus Medical, Inc. · 2009
- This deviceK090952 Zyfuse Facet Fixation SystemGlobus Medical, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083442 | Corridor Fixation System | Globus Medical, Inc. | 2009 | — |
| 0 (this device) | K090952 | Zyfuse Facet Fixation System | Globus Medical, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K083442 | Corridor Fixation SystemSummary page 1…inical Affairs & Regulatory Device Name: ZYFUSE Tm Facet Fixation System Classification: Product Code MRW. Unclassified. Predicate(s): CORRI DOR Fixation System (K083442) Device Description: The ZYFUSE Tm Facet Fixation System consists of screws designed to compact juxtaposed facet articular proce… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K083442.
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. 2009, 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 ZYFUSE MT Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from LI to S1. 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…
Read the full statement (163 words)
The ZYFUSE MT Facet Fixation System is intended to stabilize the spine as an aid
to fusion through bilateral immobilization of the facet joints, with or without bone
graft, at single or multiple levels, from LI to S1. 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 ZYFUSE MT Facet Fixation System is indicated for treatment of any or all of
the following: pseudoarthrosis and failed previous fusions which are symptomatic
or which may cause secondary instability or deformity; spondylolisthesis;
spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back
pain of discogenic origin as confirmed by radiographic studies; degeneration of
the facets with instability and trauma including spinal fractures and/or
dislocations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090952: Zyfuse Facet 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/K090952
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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