510(k) · Cleared
ClearedArthrex Spine Compression FT Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MRW System, Facet Screw Spinal Device
Cleared on May 22, 2025 as substantially equivalent to K192744 (Globus Medical, Inc., 2019) and 5 other predicates after a 56-day review. Its family tree reaches back 13 generations to 2000. 1 later device descends from it.
- Decided
- May 22, 2025
- Review
- 56 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K000684 (2000). 121 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 9 generations between
- 3 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 2 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 1 generation backK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- This deviceK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 12 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 11 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 10 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 9 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 8 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 7 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 6 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 5 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 4 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 3 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 2 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 1 generation backK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- This deviceK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −12 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −11 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −10 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −9 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −8 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −7 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −6 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −5 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −4 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −3 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −2 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| −1 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +1 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 14 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K192744 | CORRIDOR Fixation SystemSummary page 5…fastener, Class II (Product Code: HWC) - Panel Code 87 Predicate Devices CORRIDOR Fixation System, Globus Medical Inc.(K192744) (Primary Predicate) Arthrex Compression FT Screw (K201132) (Additional Predicate… | 2019 |
| * | K201132 | Arthrex Compression ScrewsSummary page 5…te Devices CORRIDOR Fixation System, Globus Medical Inc.(K192744) (Primary Predicate) Arthrex Compression FT Screw (K201132) (Additional Predicate) Purpose of Submission This Traditional 510(k) premarket notification is submitted to… | 2020 |
| * | K182361 | Arthrex Compression FT ScrewsSummary page 7…K250920 - Page 3 of 3 Corridor Fixation System (K192744) and Arthrex Compression FT Screw (K201132, K182361, K170382, K150456, K132217) devices. Conclusion Based on the intended use, fundamental scientific technology, and… | 2018 |
| * | K170382 | Arthrex Compression ScrewsSummary page 7…K250920 - Page 3 of 3 Corridor Fixation System (K192744) and Arthrex Compression FT Screw (K201132, K182361, K170382, K150456, K132217) devices. Conclusion Based on the intended use, fundamental scientific technology, and the data… | 2017 |
| * | K150456 | Arthrex Plates, Screws, and StaplesSummary page 7…K250920 - Page 3 of 3 Corridor Fixation System (K192744) and Arthrex Compression FT Screw (K201132, K182361, K170382, K150456, K132217) devices. Conclusion Based on the intended use, fundamental scientific technology, and the data provided… | 2015 |
| * | K132217 | Arthrex Compression FT ScrewsSummary page 7…K250920 - Page 3 of 3 Corridor Fixation System (K192744) and Arthrex Compression FT Screw (K201132, K182361, K170382, K150456, K132217) devices. Conclusion Based on the intended use, fundamental scientific technology, and the data provided in this T… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262618 | Arthrex Spine Compression FT Screw | 2026 | 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 25 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 121 ancestors have a recall of any class.
- Of its descendants, K262618 (Arthrex, Inc., 2026) has gone furthest, with 0 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. 2025, 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 Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following…
Read the full statement (167 words)
The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, 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 and trauma including spinal fractures and/or dislocations.
The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250920 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250920: Arthrex Spine Compression FT Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250920
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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