510(k) · Cleared
ClearedCorridor 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 Feb 6, 2009 after a 78-day review. The FDA summary names no predicate by number. 12 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 78 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 5 citing it directly.
- This deviceK083442 Corridor Fixation SystemGlobus Medical, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK180729 FaSet Fixation SystemHuvexel Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK222515 FaSet Fixation SystemDio Medical Corporation · 2022
- Descendant · cites it directly · 2 of its ownK192744 CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK101364 Lanx Facet Screw SystemLanx, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K180729FaSet Fixation SystemHuvexel Co., Ltd. · 2018 · cites it directly3descendants
- K222515FaSet Fixation SystemDio Medical Corporation · 2022 · 2 generations on2descendants
- K192744CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019 · cites it directly2descendants
- K101364Lanx Facet Screw SystemLanx, Inc. · 2010 · cites it directly2descendants
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083442 | Corridor Fixation System | Globus Medical, Inc. | 2009 | — |
| +1 | K180729 | FaSet Fixation System | Huvexel Co., Ltd. | 2018 | — |
| +2 | K222515 | FaSet Fixation System | Dio Medical Corporation | 2022 | — |
| +1 | K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019 | — |
| +1 | K101364 | Lanx Facet Screw System | Lanx, Inc. | 2010 | — |
| +2 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 125 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?
- Of its descendants, K180729 (Huvexel Co., Ltd., 2018) has gone furthest, with 3 descendants 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. 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 CORRIDOR TM 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 C2 to S1 for 3.5mm and 4.0mm screws and from Li to S1 for 4.5mm screws. 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…
Read the full statement (173 words)
The CORRIDOR TM 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 C2 to S1 for 3.5mm and 4.0mm screws and from Li to S1 for 4.5mm screws. 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 CORRIDORTM 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/K083442 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083442: Corridor 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/K083442
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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