510(k) · Cleared
ClearedPMT Facet Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Medical Technology, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Oct 11, 2019 as substantially equivalent to K020411 (Nuvasive, Inc., 2002) and 1 other predicate after a 294-day review. Its family tree reaches back 5 generations to 1997. 8 later devices descend from it.
- Decided
- Oct 11, 2019
- Review
- 294 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K953076 (1997). 13 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 4 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 3 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 2 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 1 generation backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- This deviceK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK241035 PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253676 CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251714 Ion-CSurGenTec, LLC · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022 · cites it directly7descendants
- K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024 · 2 generations on4descendants
- K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025 · 2 generations on1descendant
- K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026 · 3 generations on0descendants
- K251714Ion-CSurGenTec, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −4 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −3 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −2 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −1 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| 0 (this device) | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
| +1 | K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022 | — |
| +2 | K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024 | — |
| +2 | K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025 | — |
| +3 | K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | 2026 | — |
| +2 | K251714 | Ion-C | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 4…stem, Facet Screw Spinal Device Product Code, Class: MRW, Unclassified Predicate Devices: Primary Predicate: NuVasive Triad Facet Screw System (K020411, cleared 3/12/2012) Additional Predicate: Venus Facet Screw System (K120340, cleared 10/19/12) Indications for Use:… | 2002 |
| * | K120340 | Venus Facet Screw SystemSummary page 4…ied Predicate Devices: Primary Predicate: NuVasive Triad Facet Screw System (K020411, cleared 3/12/2012) Additional Predicate: Venus Facet Screw System (K120340, cleared 10/19/12) Indications for Use: The PMT Facet Screw is intended to stabilize the spine as an aid to fusion throu… | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220951 | PMT Facet Fixation System (PMT FFS) | 2022 | 7 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K220951 (Providence Medical Technology, Inc., 2022) has gone furthest, with 7 descendants of its own.
- 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. 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 PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the…
Read the full statement (133 words)
The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:
1. Pseudoarthrosis and failed previous fusion
2. Spondylolisthesis
3. Spondylolysis
4. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
5. Degeneration of the facets with instability; and
6. Fracture
The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183589: PMT Facet Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183589
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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