510(k) · Cleared
ClearedArthrex Compression Screws
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 Jul 27, 2020 as substantially equivalent to K103705 (Arthrex, Inc., 2011) and 5 other predicates after a 90-day review. Its family tree reaches back 12 generations to 2000. 11 later devices descend from it.
- Decided
- Jul 27, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K000684 (2000). 94 ancestors in all, the oldest K792022 (1979). 11 later devices descend from it, 8 citing it directly.
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations between
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 1 generation backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- This deviceK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK254215 Arthrex Beaming SystemArthrex, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK243195 Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK242554 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK241592 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 11 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 10 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 9 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 8 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 7 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 6 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 5 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 4 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 1 generation backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- This deviceK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K254215Arthrex Beaming SystemArthrex, Inc. · 2026 · cites it directly1descendant
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · cites it directly1descendant
- K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2025 · cites it directly1descendant
- K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024 · cites it directly1descendant
- K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −11 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −10 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −9 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −8 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −7 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −6 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −5 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −4 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −2 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −1 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| 0 (this device) | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| +1 | K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026 | — |
| +1 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +1 | K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2025 | — |
| +1 | K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024 | — |
| +1 | K241592 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 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? (6)
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 5…ries (Primary) 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K103705: Arthrex Low Profile Screws (Primary) K111253: Arthrex Distal Extremity Plate System… | 2011 |
| * | K111253 | Arthrex Distal Extremity Plate SystemSummary page 5…aded metallic bone fixation fastener Regulatory Class II Predicate Device K103705: Arthrex Low Profile Screws (Primary) K111253: Arthrex Distal Extremity Plate System K131474: Arthrex Distal Radius Plate System… | 2011 |
| * | K131474 | Arthrex Distal Radius Plate SystemSummary page 5…ate Device K103705: Arthrex Low Profile Screws (Primary) K111253: Arthrex Distal Extremity Plate System K131474: Arthrex Distal Radius Plate System K141735: Arthrex Ankle Fusion Plating System… | 2013 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 5…K111253: Arthrex Distal Extremity Plate System K131474: Arthrex Distal Radius Plate System K141735: Arthrex Ankle Fusion Plating System K151732: Arthrex Fracture Plates K17… | 2014 |
| * | K151732 | Arthrex Fracture PlatesSummary page 5…K131474: Arthrex Distal Radius Plate System K141735: Arthrex Ankle Fusion Plating System K151732: Arthrex Fracture Plates K170547: Arthrex Mesh Plates Purpose of This Traditional 51… | 2015 |
| * | K170547 | Arthrex Mesh Plate SystemSummary page 5…System K141735: Arthrex Ankle Fusion Plating System K151732: Arthrex Fracture Plates K170547: Arthrex Mesh Plates Purpose of This Traditional 510(k) premarket notification is submitted to obtain clearance… | 2017 |
What descends from it? (11)
See all 118 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254215 | Arthrex Beaming System | 2026 | 1 |
| K250920 | Arthrex Spine Compression FT Screw | 2025 | 1 |
| K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | 2025 | 1 |
| K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | 2024 | 1 |
| K241592 | Arthrex VAL and VAL KreuLock™ Compression Screw System | 2024 | 1 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | 2026 | 0 |
| K213614 | Cannulated Screws | 2022 | 0 |
| K210994 | Arthrex Beveled FT Screws | 2021 | 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 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 94 ancestors have a recall of any class.
- Of its descendants, K254215 (Arthrex, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 21 other devices also cite its predicate K103705.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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, and wrist. 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 KreuLock Compression Screws (3.5 mm and…
Read the full statement (229 words)
The Arthrex 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, and wrist. 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 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, 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 Compression FT Screws (2.0-3.0 mm 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 Compression FT Screws (3.5 mm 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, calcaneus, femur and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201132: Arthrex Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201132
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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