510(k) · Cleared
ClearedFRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortler Global Tibbi Gerecler Anonim Sirketi · HRS Plate, Fixation, Bone
Cleared on Aug 28, 2026 as substantially equivalent to K242939 (Artfx Medical, 2024) after an 87-day review. Its family tree reaches back 14 generations to 2000.
- Decided
- Aug 28, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K000684 (2000). 288 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations between
- 3 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 2 generations backK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- 1 generation backK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- This deviceK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
Show all 14 generations
- Root · 14 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 13 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 12 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 11 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 10 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 9 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 8 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 7 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 6 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 5 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 4 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 3 generations backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- 2 generations backK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- 1 generation backK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- This deviceK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −13 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −12 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −11 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −10 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −9 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −8 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −7 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −6 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −5 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −4 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −3 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| −2 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| −1 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| 0 (this device) | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 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 |
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? (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 |
|---|---|---|---|
| * | K242939 | ARTFX Trauma Bone Plate and Screw SystemSummary page 5….3030 Product Code(s) HRS, HWC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K242939 ARTFX 3.5 Plate System ; ARTFX 4.5 Plate System; ARTFX HRS Mini Plate System; ARTFX Bone Screw System Device Description Summary… | 2024 |
| † | K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 60 of the 288 ancestors have a recall of any class.
- 1 other device also cites its predicate K242939.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 FRAXION 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 FRAXION Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic…
Read the full statement (166 words)
The FRAXION 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 FRAXION 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 FRAXION 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 FRAXION 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 FRAXION 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261830
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026