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 Sep 24, 2026 as substantially equivalent to K250920 (Arthrex, Inc., 2025) after a 58-day review. Its family tree reaches back 14 generations to 2000.
- Decided
- Sep 24, 2026
- Review
- 58 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K000684 (2000). 122 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations between
- 3 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 2 generations backK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- 1 generation backK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- This deviceK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 13 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 12 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 11 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 10 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 9 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 8 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 7 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 6 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 5 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 4 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 3 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 2 generations backK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- 1 generation backK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- This deviceK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −13 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −12 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −11 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −10 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −9 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −8 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −7 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −6 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −5 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −4 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −3 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| −2 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| −1 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K250920 | Arthrex Spine Compression FT ScrewSummary page 5…) - Panel Code 87 Regulatory Class Class II Primary Predicate Device Arthrex Spine Compression FT Screw K250920 (S.E. May 22, 2025) Reference Devices Arthrex Univers Revers Monoblock Stem K230366 (S.E. Apr… | 2025 |
| † | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | 2023 |
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 4 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 122 ancestors have a recall of any class.
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. 2026, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262618: Arthrex Spine Compression FT Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262618
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026