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 Jan 16, 2015 as substantially equivalent to K103705 (Arthrex, Inc., 2011) after a 28-day review. Its family tree reaches back 7 generations to 2000. 19 later devices descend from it.
- Decided
- Jan 16, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000684 (2000). 29 ancestors in all, the oldest K890939 (1989). 19 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- This deviceK143614 Arthrex Low Profile ScrewsArthrex, Inc. · 2015
- Descendant · cites it directly · 15 of its ownK170547 Arthrex Mesh Plate SystemArthrex, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK201677 Arthrex Mesh PlatesArthrex, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK254215 Arthrex Beaming SystemArthrex, Inc. · 2026
- Descendant · 3 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K170547Arthrex Mesh Plate SystemArthrex, Inc. · 2017 · cites it directly15descendants
- K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · 2 generations on11descendants
- K201677Arthrex Mesh PlatesArthrex, Inc. · 2020 · 2 generations on2descendants
- K254215Arthrex Beaming SystemArthrex, Inc. · 2026 · 3 generations on1descendant
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K143614 | Arthrex Low Profile Screws | Arthrex, Inc. | 2015 | — |
| +1 | K170547 | Arthrex Mesh Plate System | Arthrex, Inc. | 2017 | — |
| +2 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| +2 | K201677 | Arthrex Mesh Plates | Arthrex, Inc. | 2020 | — |
| +3 | K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026 | — |
| +3 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K103705 | Low Profile ScrewsSummary page 4…n fastener Predicate Device K103705: Arthrex Low Profile Screws Purpose of Submission… | 2011 |
What descends from it? (19)
See all 194 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 29 ancestors have a recall of any class.
- Of its descendants, K170547 (Arthrex, Inc., 2017) has gone furthest, with 15 descendants of its own.
- 21 other devices also cite its predicate K103705.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates. The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws…
Read the full statement (215 words)
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143614: 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/K143614
Report an extraction error
Are you the manufacturer?
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