510(k) · Cleared
ClearedALLY™ Facet Screws
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 Feb 16, 2017 as substantially equivalent to K092568 (Amendia, Inc., 2009) and 2 other predicates after a 77-day review. Its family tree reaches back 5 generations to 1997. 18 later devices descend from it.
- Decided
- Feb 16, 2017
- Review
- 77 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K953076 (1997). 15 ancestors in all. 18 later devices descend from it, 3 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 deviceK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- Descendant · cites it directly · 10 of its ownK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- Descendant · cites it directly · 9 of its ownK230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK232468 SC Medica FFXSc Medica · 2024
- Descendant · 2 generations on · 3 of its ownK240086 Ion 3DSurGenTec, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK252153 FFX Facet Fixation SystemSc Medica · 2025
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K211855Ion Facet Screw SystemSurGenTec, LLC · 2022 · cites it directly10descendants
- K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023 · cites it directly9descendants
- K232468SC Medica FFXSc Medica · 2024 · 2 generations on3descendants
- K240086Ion 3DSurGenTec, LLC · 2024 · 2 generations on3descendants
- K252153FFX Facet Fixation SystemSc Medica · 2025 · 2 generations on2descendants
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) | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| +1 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| +1 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023 | — |
| +2 | K232468 | SC Medica FFX | Sc Medica | 2024 | — |
| +2 | K240086 | Ion 3D | SurGenTec, LLC | 2024 | — |
| +2 | K252153 | 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 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K092568 | Spartan S3 Facet SystemSummary page 4…System, Facet Screw Spinal Device Product Code, Class: MRW, Unclassified Predicate Devices: Primary Predicate: SpartanS3 Facet System (K092568, cleared 11/17/09) (This device has not been subject to recall.) Additional Predicates: Venus F… | 2009 |
| * | K120340 | Venus Facet Screw SystemSummary page 4…Facet System (K092568, cleared 11/17/09) (This device has not been subject to recall.) Additional Predicates: Venus Facet Screw System (K120340, cleared 10/19/12) Facet Fixx (K131417, cleared 7/12/13) Indications for Use: The ALLY™ Facet Screw… | 2012 |
| * | K131417 | Facet FixxSummary page 4…(This device has not been subject to recall.) Additional Predicates: Venus Facet Screw System (K120340, cleared 10/19/12) Facet Fixx (K131417, cleared 7/12/13) Indications for Use: The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all… | 2013 |
What descends from it? (18)
See all 183 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 20 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, K211855 (SurGenTec, LLC, 2022) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K092568.
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. 2017, 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 ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or…
Read the full statement (110 words)
The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
1) Trauma, including spinal fractures and/or dislocations;
2) Spondylolisthesis;
3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and
4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163374: ALLY™ Facet Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163374
Report an extraction error
Are you the manufacturer?
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