510(k) · Cleared
ClearedARTFX Trauma Bone Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artfx Medical · HRS Plate, Fixation, Bone
Cleared on Dec 23, 2024 as substantially equivalent to K191793 (Nebula Surgical Private Limited, 2019) and 5 other predicates after an 89-day review. Its family tree reaches back 13 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 23, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K000684 (2000). 287 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 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 backK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- This deviceK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · cites it directly · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
- Descendant · cites it directly · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 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 backK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- This deviceK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| 0 (this device) | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +1 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
| +1 | K260277 | Mikron Trauma Bone Plate& Screw System | Mikron Makina San. ve Tic. Ltd. Sti. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 20 | 0 |
| 1997 | 6 | 0 |
| 1998 | 17 | 0 |
| 1999 | 9 | 0 |
| 2000 | 18 | 0 |
| 2001 | 18 | 0 |
| 2002 | 11 | 0 |
| 2003 | 19 | 0 |
| 2004 | 18 | 0 |
| 2005 | 20 | 0 |
| 2006 | 17 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 16 | 0 |
| 2010 | 13 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Summary page 8…ned with their respective predicate devices. Subject System(s) Primary Predicate Device Additional Predicate Device(s) K191793 - Nebula Brand Locking Bone K171808 - TDM Plate and Screw System,… | 2019 |
| * | K171808 | TDM Plate and Screw SystemSummary page 8…Additional Predicate Device(s) K191793 - Nebula Brand Locking Bone K171808 - TDM Plate and Screw System, Plates and Screws Osteosynthesis ARTFX 3.5 System… | 2018 |
| * | K161894 | SurgTech Trauma SystemSummary page 8…K171808 - TDM Plate and Screw System, Plates and Screws Osteosynthesis ARTFX 3.5 System K161894 - SurgTech Trauma System, Plating System, Nebula Brand of DHS… | 2017 |
| * | K171904 | Tandry Locking Plate SystemSummary page 8…K161894 - SurgTech Trauma System, Plating System, Nebula Brand of DHS K171904 - Tandry Locking Plate System Plating System K191793 - Nebula Brand Locking Bone K163… | 2018 |
| * | K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Summary page 8…K171904 - Tandry Locking Plate System Plating System K191793 - Nebula Brand Locking Bone K163383 - GREENS BRAND Locking Bone ARTFX 4.5 System Plates and Screws Osteosynthesis Plates and Screws… | 2017 |
| * | K142419 | Mini and Micro Fragments Reconstruction System-NEOFIXSummary page 9…ng System, Nebula Brand of DHS Plating System Plating System K161894 - SurgTech Trauma System ARTFX Mini-Plate K142419 - Mini and Micro Fragments K171904 - Tandry Locking Plate System,… | 2014 |
| † | K212220 | ArtFX Spinal Fixation System | 2023 |
What descends from it? (2)
2 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 24 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 60 of the 287 ancestors have a recall of any class.
- Of its descendants, K261830 (Ortler Global Tibbi Gerecler Anonim Sirketi, 2026) has gone furthest, with 0 descendants of its own.
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 ARTFX Trauma Bone Plate and Screw System is indicated for fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or…
Read the full statement (166 words)
The ARTFX Trauma Bone Plate and Screw System is indicated for fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine, nor for fixation of the sacroiliac joint. The system is intended for single use and for adult patients only.
The ARTFX 3.5 System is indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpal, phalangeal), fibula, foot (tarsal, metatarsal, phalangeal), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.
The ARTFX 4.5 System is indicated for fixation of lower extremity (femur, tibia, fibula) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.
The ARTFX Mini-Plate System is indicated for fixation of hand (metacarpal, phalangeal) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242939: ARTFX Trauma Bone Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242939
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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