510(k) · Cleared
ClearedPMT Facet Fixation System, Lumbar (PMT FFS-LX)
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 19, 2023 as substantially equivalent to K163374 (Providence Medical Technology, Inc., 2017) after a 267-day review. Its family tree reaches back 6 generations to 1997. 9 later devices descend from it.
- Decided
- Dec 19, 2023
- Review
- 267 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953076 (1997). 16 ancestors in all. 9 later devices descend from it, 6 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 backK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- This deviceK230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK232468 SC Medica FFXSc Medica · 2024
- Descendant · cites it directly · 2 of its ownK252153 FFX Facet Fixation SystemSc Medica · 2025
- Descendant · cites it directly · 2 of its ownK240085 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK251885 CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261209 Ion-LSurGenTec, LLC · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K232468SC Medica FFXSc Medica · 2024 · cites it directly3descendants
- K252153FFX Facet Fixation SystemSc Medica · 2025 · cites it directly2descendants
- K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024 · cites it directly2descendants
- K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025 · cites it directly1descendant
- K261209Ion-LSurGenTec, LLC · 2026 · cites it directly0descendants
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 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| 0 (this device) | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023 | — |
| +1 | K232468 | SC Medica FFX | Sc Medica | 2024 | — |
| +1 | K252153 | FFX Facet Fixation System | Sc Medica | 2025 | — |
| +1 | K240085 | zLOCK Lumbar Facet Fixation System | Zygofix, Ltd. | 2024 | — |
| +1 | K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025 | — |
| +1 | K261209 | Ion-L | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 5 | 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 K211855 Ion Facet Screw Systemscore 22.4 · 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 |
|---|---|---|---|
| * | K163374 | ALLY™ Facet ScrewsSummary page 4…ision of Health Technology & Panel: 6B (DHT6B); Orthopedic and Rehabilitation Devices Panel Primary Predicate Device: ALLY Facet Screws (K163374), Product Code MRW, Unclassified Reference Devices: PMT Facet Fixation System (FFS) (K220951), Product Code MRW, U… | 2017 |
| † | K220951 | PMT Facet Fixation System (PMT FFS) | 2022 |
| † | K230297 | PMT Expandable Cage (PMT EXP) | 2023 |
What descends from it? (9)
6 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 26 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K232468 (Sc Medica, 2024) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K163374.
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. 2023, 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, Lumbar (PMT FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. PMT FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be…
Read the full statement (135 words)
PMT Facet Fixation System, Lumbar (PMT FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. PMT FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.
PMT FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s).
PMT FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230840
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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