510(k) · Cleared
ClearedFacet Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · MRW System, Facet Screw Spinal Device
Cleared on Jan 3, 2018 as substantially equivalent to K020411 (Nuvasive, Inc., 2002) and 2 other predicates after a 93-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 3, 2018
- Review
- 93 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K994308 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −1 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| 0 (this device) | K173198 | Facet Screw Fixation System | U&I Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 4…Unclassified Common Name: System, Facet Screw Spinal Device Product Code: MRW Predicate Devices: NuVasiveTM TriadTM Facet Screw System (K020411) [Primary] Resolute Facet Screw System (K121551) DISCOVERY Facet Screw Fixation… | 2002 |
| * | K121551 | Resolute Facet Screw SystemSummary page 4…e Product Code: MRW Predicate Devices: NuVasiveTM TriadTM Facet Screw System (K020411) [Primary] Resolute Facet Screw System (K121551) DISCOVERY Facet Screw Fixation System(K012773) Description of Device: The Facet Screw Fixation System… | 2012 |
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 4…adTM Facet Screw System (K020411) [Primary] Resolute Facet Screw System (K121551) DISCOVERY Facet Screw Fixation System(K012773) Description of Device: The Facet Screw Fixation System is manufactured by U&I Corporation. The Facet Screw Fixation System is… | 2001 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- None of the 5 ancestors has a recall.
- 10 other devices also cite its predicate K020411.
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 Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw Fixation System 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…
Read the full statement (169 words)
The Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw Fixation System 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 Facet Screw Fixation System is indicated for treatment for any or all of the following:
Spondylolisthesis
Spondylolysis
Pseudoarthrosis or failed previous fusions which are symptomatic
Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disk 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173198: Facet Screw 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/K173198
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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