510(k) · Cleared
ClearedProficient (TM) Facet Screw Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Jan 16, 2015 as substantially equivalent to K073515 (Trans1 Incorporated, 2008) and 2 other predicates after a 93-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jan 16, 2015
- Review
- 93 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K953076 (1997). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK142980 Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc. · 2015
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) | K142980 | Proficient (TM) Facet Screw Spine System | Spine Wave, Inc. | 2015 | — |
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 |
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 |
|---|---|---|---|
| * | K073515 | TRANS1 Facet ScrewSummary page 4…to the following predicates: Primary Predicate Device Manufacturer 510(k) Number TranS1® Facet Screws Trans1® K073515 Additional Predicate Devices Manufacturer 510(k) Number Venus Facet Screw System Apollo Spin… | 2008 |
| * | K120340 | Venus Facet Screw SystemSummary page 4…ans1® K073515 Additional Predicate Devices Manufacturer 510(k) Number Venus Facet Screw System Apollo Spine K120340 CS Facet Compression Device Triage Medical, Inc K052043… | 2012 |
| * | K052043 | 3.8MM CS Facet Compression DeviceSummary page 4…anufacturer 510(k) Number Venus Facet Screw System Apollo Spine K120340 CS Facet Compression Device Triage Medical, Inc K052043 K142980 - Page 2 of 2 5. Device Description Th… | 2005 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 10 other devices also cite its predicate K073515.
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. 2015, 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 Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Proficient™ Facet…
Read the full statement (143 words)
The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine System is indicated for treatment of any or all of the following:
• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
• Spondylolisthesis
• Spondylolysis
• Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
• Degeneration of the facets with instability
• Trauma including spinal fractures and/or dislocations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142980 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142980: Proficient (TM) Facet Screw Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142980
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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