510(k) · Cleared
ClearedPMT Facet Fixation System (PMT FFS)
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 Dec 9, 2022 as substantially equivalent to K183589 (Providence Medical Technology, Inc., 2019) after a 252-day review. Its family tree reaches back 6 generations to 1997. 7 later devices descend from it.
- Decided
- Dec 9, 2022
- Review
- 252 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953076 (1997). 14 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 5 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 4 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 3 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 2 generations backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- 1 generation backK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
- This deviceK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK241035 PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253676 CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251714 Ion-CSurGenTec, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK250679 FFX Facet Fixation SystemSc Medica · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. · 2024 · cites it directly4descendants
- K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025 · cites it directly1descendant
- K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026 · 2 generations on0descendants
- K251714Ion-CSurGenTec, LLC · 2026 · cites it directly0descendants
- K250679FFX Facet Fixation SystemSc Medica · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −5 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −4 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −3 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −2 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| −1 | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
| 0 (this device) | K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022 | — |
| +1 | K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024 | — |
| +1 | K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025 | — |
| +2 | K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | 2026 | — |
| +1 | K251714 | Ion-C | SurGenTec, LLC | 2026 | — |
| +2 | K250679 | FFX Facet Fixation System | Sc Medica | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K183589 | PMT Facet ScrewSummary page 4…Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Primary Predicate Device: PMT Facet Screw cleared under K183589 (code MRW) Reference Devices: CAVUX® Cage (K122801) and ALLY® Bone Screw (K170698) Device Description The PMT Facet… | 2019 |
| † | K122801 | Providence Cervical Cage | 2013 |
| † | K170698 | ALLY (TM) Bone Screws | 2017 |
What descends from it? (7)
4 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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K241035 (Providence Medical Technology, Inc., 2024) has gone furthest, with 4 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. 2022, 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?
PMT Facet Fixation System (PMT FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. PMT FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. PMT FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. PMT FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220951: PMT Facet Fixation System (PMT FFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220951
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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