510(k) · Cleared
ClearedArthrex Low Profile Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Oct 30, 2019 as substantially equivalent to K141735 (Arthrex, Inc., 2014) after a 204-day review. Its family tree reaches back 11 generations to 2000.
- Decided
- Oct 30, 2019
- Review
- 204 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K000684 (2000). 76 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations between
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- This deviceK190921 Arthrex Low Profile ScrewsArthrex, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 9 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 8 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 7 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 6 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 5 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 4 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- This deviceK190921 Arthrex Low Profile ScrewsArthrex, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −10 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −9 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −8 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −7 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −6 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −5 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −4 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −2 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −1 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| 0 (this device) | K190921 | Arthrex Low Profile Screws | Arthrex, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 4…21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Predicate Device K141735 – Arthrex Ankle Fusion Plating System Purpose of Submission This Special 510(k) premarket notification is submitted to obtain c… | 2014 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 76 ancestors have a recall of any class.
- 11 other devices also cite its predicate K141735.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190921: Arthrex Low Profile Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190921
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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