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. · HRS Plate, Fixation, Bone
Cleared on Oct 21, 2024 as substantially equivalent to K201132 (Arthrex, Inc., 2020) and 4 other predicates after a 55-day review. Its family tree reaches back 16 generations to 1979. 1 later device descends from it.
- Decided
- Oct 21, 2024
- Review
- 55 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K792022 (1979). 208 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 12 generations between
- 3 generations backK180500 VariAx 2 SystemStryker GmbH · 2018
- 2 generations backK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- 1 generation backK220937 Arthrex Mini Fragment SystemArthrex, Inc. · 2022
- This deviceK242554 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 16 generations
- Root · 16 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 15 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 14 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 13 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 12 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 11 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 10 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 9 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 8 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 7 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 6 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 5 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 4 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 3 generations backK180500 VariAx 2 SystemStryker GmbH · 2018
- 2 generations backK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- 1 generation backK220937 Arthrex Mini Fragment SystemArthrex, Inc. · 2022
- This deviceK242554 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 |
|---|---|---|---|---|---|
| −16 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −15 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −14 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −13 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −12 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −11 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −10 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −9 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −8 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −7 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −6 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −5 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| −4 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| −3 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| −2 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
| −1 | K220937 | Arthrex Mini Fragment System | Arthrex, Inc. | 2022 | — |
| 0 (this device) | K242554 | 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 |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 11 | 0 |
| 1996 | 17 | 0 |
| 1997 | 9 | 0 |
| 1998 | 10 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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…21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener Regulatory Class II Primary Predicate Device K201132 Arthrex Compression Screws Additional Predicate K220937 Arthrex Mini Fragment System Devices K203294 Art… | 2020 |
| * | K220937 | Arthrex Mini Fragment SystemSummary page 5…bone fixation fastener Regulatory Class II Primary Predicate Device K201132 Arthrex Compression Screws Additional Predicate K220937 Arthrex Mini Fragment System Devices K203294 Arthrex Pilon Fusion System K103705 Ar… | 2022 |
| * | K203294 | Arthrex Pilon Fusion SystemSummary page 5…ass II Primary Predicate Device K201132 Arthrex Compression Screws Additional Predicate K220937 Arthrex Mini Fragment System Devices K203294 Arthrex Pilon Fusion System K103705 Arthrex Low Profile Screws K082516 Smit… | 2021 |
| * | K103705 | Low Profile ScrewsSummary page 5…pression Screws Additional Predicate K220937 Arthrex Mini Fragment System Devices K203294 Arthrex Pilon Fusion System K103705 Arthrex Low Profile Screws K082516 Smith & Nephew PERI-LOC Hexalobular Bone… | 2011 |
| * | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSummary page 5…i Fragment System Devices K203294 Arthrex Pilon Fusion System K103705 Arthrex Low Profile Screws K082516 Smith & Nephew PERI-LOC Hexalobular Bone Screws Purpose of Submission This Traditional 510(k) pre… | 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 45 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 39 of the 208 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 HRS devicesHRS Plate, 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 · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 mm 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, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle and scapula. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates…
Read the full statement (259 words)
The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 mm 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, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle and scapula. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.
The Arthrex Hybrid KreuLock™ 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 Hybrid Low Profile VAL 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, 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.
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/K242554 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242554: 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 3, 2026. https://510kreport.com/device/K242554
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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