510(k) · Cleared
ClearedPMT Expandable Cage (PMT EXP)
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 Aug 11, 2023 as substantially equivalent to K220951 (Providence Medical Technology, Inc., 2022) and 1 other predicate after a 190-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Aug 11, 2023
- Review
- 190 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K953076 (1997). 18 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK230297 PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc. · 2023
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) | K230297 | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | 2023 | — |
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 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K220951 | PMT Facet Fixation System (PMT FFS)Summary page 4…mmon Name: Facet Screw System Regulatory Class: Unclassified Product Code: MRW Primary Predicate Device: PMT Facet Fixation Screw (FFS), K220951 (Code MRW) Additional Predicate: ALLY Facet Screw, K163374 (Product Code MRW) Device Description The PMT Expandable Cage (PM… | 2022 |
| * | K163374 | ALLY™ Facet ScrewsSummary page 4…Unclassified Product Code: MRW Primary Predicate Device: PMT Facet Fixation Screw (FFS), K220951 (Code MRW) Additional Predicate: ALLY Facet Screw, K163374 (Product Code MRW) Device Description The PMT Expandable Cage (PMT EXP) is comprised of a CAVUX Cage-E and an ALLY Expansion Scr… | 2017 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 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. 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 Expandable Cage (PMT EXP) is an integrated construct comprised of a CAVUX Cage-E and a single ALLY Screw-E. PMT EXP is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT EXP is intended for temporary stabilization as an adjunct to single level posterior cervical fusion in skeletally mature patients. PMT EXP is only intended for use with a single level…
Read the full statement (126 words)
PMT Expandable Cage (PMT EXP) is an integrated construct comprised of a CAVUX Cage-E and a single ALLY Screw-E.
PMT EXP is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.
PMT EXP is intended for temporary stabilization as an adjunct to single level posterior cervical fusion in skeletally mature patients. PMT EXP is only intended for use with a single level anterior cervical fusion at the same spinal level that utilizes FDA cleared/approved spine stabilization hardware for anterior cervical fusion procedures.
PMT EXP is indicated for the treatment of patients with cervical degenerative disc disease (DDD) with radiculopathy from C3-C7.
PMT EXP is indicated for use with autogenous and/or allogenic bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230297: PMT Expandable Cage (PMT EXP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230297
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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