510(k) · Cleared
ClearedArthrex VAL and VAL KreuLock™ Compression Screw System
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 Aug 31, 2024 as substantially equivalent to K201132 (Arthrex, Inc., 2020) and 2 other predicates after an 89-day review. Its family tree reaches back 13 generations to 2000. 1 later device descends from it.
- Decided
- Aug 31, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K000684 (2000). 95 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 deviceK241592 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260809 Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, 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 deviceK241592 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, 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) | K241592 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024 | — |
| +1 | K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | 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 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K201132 | Arthrex Compression ScrewsSummary page 5…Product Code HWC Classification Name 21 CFR 888.3040 Screw, Fixation, Bone Regulatory Class II Primary Predicate Device K201132 Arthrex Compression Screws Additional Predicate Device(s) K103705 Arthrex Low Profile Screws K1436… | 2020 |
| * | K103705 | Low Profile ScrewsSummary page 5…21 CFR 888.3040 Screw, Fixation, Bone Regulatory Class II Primary Predicate Device K201132 Arthrex Compression Screws Additional Predicate Device(s) K103705 Arthrex Low Profile Screws K143614 Arthrex Low Profile VAL Screw Reference Device K0… | 2011 |
| * | K143614 | Arthrex Low Profile ScrewsSummary page 5…II Primary Predicate Device K201132 Arthrex Compression Screws Additional Predicate Device(s) K103705 Arthrex Low Profile Screws K143614 Arthrex Low Profile VAL Screw Reference Device K082516 Smith & Nephew PERI-LOC Hexalobular Bone… | 2015 |
| † | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | 2008 |
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 |
|---|---|---|---|
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | 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 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 95 ancestors have a recall of any class.
- Of its descendants, K260809 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K201132.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 VAL KreuLockTM Compression Screws (3.5 mm and larger, solid) are intended to be used 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, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate…
Read the full statement (179 words)
The Arthrex VAL KreuLockTM Compression Screws (3.5 mm and larger, solid) are intended to be used 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, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex VAL Screws (3.5 mm 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, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241592 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241592: Arthrex VAL and VAL KreuLock™ Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241592
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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