510(k) · Cleared
ClearedPMT Posterior Cervical Stabilization System (PCSS)
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 Jun 25, 2024 as substantially equivalent to K220951 (Providence Medical Technology, Inc., 2022) after a 70-day review. Its family tree reaches back 7 generations to 1997. 4 later devices descend from it.
- Decided
- Jun 25, 2024
- Review
- 70 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K953076 (1997). 15 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 6 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 5 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 4 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 3 generations backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- 2 generations backK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
- 1 generation backK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
- This deviceK241035 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 · cites it directly · 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 ownK250679 FFX Facet Fixation SystemSc Medica · 2025
- Descendant · 2 generations on · 0 of its ownK253190 CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
- K250679FFX Facet Fixation SystemSc Medica · 2025 · cites it directly0descendants
- K253190CORUS-LX ImplantProvidence Medical Technology, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −6 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −5 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −4 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −3 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| −2 | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
| −1 | K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022 | — |
| 0 (this device) | 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 | — |
| +1 | K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | 2026 | — |
| +1 | K250679 | FFX Facet Fixation System | Sc Medica | 2025 | — |
| +2 | K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | 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 |
|---|---|---|
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K220951 | PMT Facet Fixation System (PMT FFS)Summary page 4…gy 6B (DHT6B); Orthopaedic and Rehabilitation Devices Panel Primary Predicate Device: PMT Facet Fixation System (“PMT FFS”), K220951, Code MRW A. Device Description PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to pr… | 2022 |
What descends from it? (4)
3 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 27 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K251885 (Providence Medical Technology, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K220951.
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. 2024, 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 PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. PMT PCSS is intended as an adjunct to posterior…
Read the full statement (140 words)
PMT PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
PMT PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.
PMT PCSS is intended as an adjunct to posterior cervical fusion (PCF), and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s).
PMT PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies.
PMT PCSS is to be used with autogenous bone and/or allogenic bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241035: PMT Posterior Cervical Stabilization System (PCSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241035
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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