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 Dec 16, 2019 as substantially equivalent to K083442 (Globus Medical, Inc., 2009) and 3 other predicates after a 77-day review. Its family tree reaches back 4 generations to 1979. 2 later devices descend from it.
- Decided
- Dec 16, 2019
- Review
- 77 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K792022 (1979). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 3 generations backK020791 HBS Headless Bone ScrewMillennium Medical Technologies, Inc. · 2002
- 2 generations backK132910 Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC · 2013
- 1 generation backK142707 AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014
- This deviceK192744 CORRIDOR Fixation SystemGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −4 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −3 | K020791 | HBS Headless Bone Screw | Millennium Medical Technologies, Inc. | 2002 | — |
| −2 | K132910 | Depuy Synthes Spine Dens Access System | Synthes USA Products, LLC | 2013 | — |
| −1 | K142707 | AIS Odontoid Fracture Fixation System | Aesculap Implant System, Inc. | 2014 | — |
| 0 (this device) | K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019 | — |
| +1 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +2 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (4)
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 4…stener Product Codes MRW, HWC Regulatory Class: Unclassified, II, Panel Code: 87 Primary Predicate: CORRIDOR® Fixation System (K083442) Additional Predicates: Aesculap Odontoid Fracture Fixation System (K142707) DePuy Synthes Dens Ac… | 2009 |
| * | K142707 | AIS Odontoid Fracture Fixation SystemSummary page 4…ss: Unclassified, II, Panel Code: 87 Primary Predicate: CORRIDOR® Fixation System (K083442) Additional Predicates: Aesculap Odontoid Fracture Fixation System (K142707) DePuy Synthes Dens Access System (K132910) Skeletal Dynamics Headless Screw System (K1… | 2014 |
| * | K132910 | Depuy Synthes Spine Dens Access SystemSummary page 4…R® Fixation System (K083442) Additional Predicates: Aesculap Odontoid Fracture Fixation System (K142707) DePuy Synthes Dens Access System (K132910) Skeletal Dynamics Headless Screw System (K143624) Purpose: The purpose of this submission is to request cl… | 2013 |
| * | K143624 | Headless Compression Screw SystemSummary page 4…Odontoid Fracture Fixation System (K142707) DePuy Synthes Dens Access System (K132910) Skeletal Dynamics Headless Screw System (K143624) Purpose: The purpose of this submission is to request clearance for additional indications for the CORRIDOR® Fixation System.… | 2015 |
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 |
|---|---|---|---|
| K250920 | Arthrex Spine Compression FT Screw | 2025 | 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 40 years and passes through 5 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K250920 (Arthrex, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 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. 2019, 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® 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 L1 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…
Read the full statement (191 words)
The CORRIDOR® 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 L1 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 CORRIDOR® 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.
The CORRIDOR® Fixation System is also indicated for fracture fixation of small bones and bone fragments including odontoid fractures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192744: CORRIDOR 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/K192744
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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