510(k) · Cleared
ClearedTRANS1 Facet Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trans1 Incorporated · MRW System, Facet Screw Spinal Device
Cleared on Mar 11, 2008 as substantially equivalent to K051856 (Trans1 Incorporated, 2005) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1997. 44 later devices descend from it.
- Decided
- Mar 11, 2008
- Review
- 88 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953076 (1997). 3 ancestors in all. 44 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 1 generation backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- This deviceK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- Descendant · cites it directly · 29 of its ownK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- Descendant · 2 generations on · 26 of its ownK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- Descendant · 2 generations on · 18 of its ownK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- Descendant · cites it directly · 11 of its ownK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
- Descendant · 2 generations on · 10 of its ownK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K092568Spartan S3 Facet SystemAmendia, Inc. · 2009 · cites it directly29descendants
- K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012 · 2 generations on26descendants
- K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017 · 2 generations on18descendants
- K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013 · cites it directly11descendants
- K211855Ion Facet Screw SystemSurGenTec, LLC · 2022 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −1 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| 0 (this device) | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| +1 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| +2 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| +2 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| +1 | K132126 | Spectrum Spine Fenestrated Facet Screw System | Spectrum Spine, LLC | 2013 | — |
| +2 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K051856 | TRANS1 Facet ScrewsSummary page 1…Facet Screw Spinal Device Classification Name: Unclassified Product Code: MRW Predicate Devices: TranS1® Facet Screws, K051856 Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System,… | 2005 |
| * | K003928 | Townley Transfacetpedicular Screw Fixation SystemSummary page 1…TranS1® Facet Screws, K051856 Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System, K003928 Sofamor Danek Transfacetpedicular Screw Fixation System, K953076 Intended use: The TranS1® Facet Scre… | 2001 |
| * | K953076 | Townley Facet/Pedicular Screw Plating SystemSummary page 1…Townley Transfacetpedicular Screw Fixation System, K003928 Sofamor Danek Transfacetpedicular Screw Fixation System, K953076 Intended use: The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterio… | 1997 |
What descends from it? (44)
See all 4411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092568 | Spartan S3 Facet System | 2009 | 29 |
| K132126 | Spectrum Spine Fenestrated Facet Screw System | 2013 | 11 |
| K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant | 2008 | 8 |
| K092464 | Spineology Facet Screw | 2009 | 6 |
| K101284 | Facet Screw System | 2010 | 2 |
| K152137 | FacetBRIDGE System | 2016 | 1 |
| K130863 | Facet Screw System | 2013 | 1 |
| K142980 | Proficient (TM) Facet Screw Spine System | 2015 | 0 |
| K120597 | Kompreda | 2013 | 0 |
| K113011 | Spartan S3 Facet System | 2011 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092568 (Amendia, Inc., 2009) has gone furthest, with 29 descendants of its own.
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. 2008, 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 TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion. The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint (usually) at a single level and into the pedicle. Alternatively, the facet screws may be…
Read the full statement (167 words)
The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion.
The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint (usually) at a single level and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process. Bone graft must be used for both fixation methods.
For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073515 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073515: TRANS1 Facet Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073515
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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