510(k) · Cleared
ClearedMikron Trauma Bone Plate& Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mikron Makina San. ve Tic. Ltd. Sti. · HRS Plate, Fixation, Bone
Cleared on Aug 13, 2026 as substantially equivalent to K242939 (Artfx Medical, 2024) and 3 other predicates after a 196-day review. Its family tree reaches back 14 generations to 2000.
- Decided
- Aug 13, 2026
- Review
- 196 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K000684 (2000). 295 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 deviceK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 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 deviceK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 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) | 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 | 12 | 0 |
| 2003 | 19 | 0 |
| 2004 | 18 | 0 |
| 2005 | 20 | 0 |
| 2006 | 17 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 17 | 0 |
| 2010 | 14 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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? (4)
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 7…21 CFR 807.92(a)(6) The subject device has the same technological characteristics in comparison to the primary predicate device (K242939-ARTFX Trauma Bone Plate and Screw System). Non-Clinical and/or Clinical Tests Summary & Conclusions… | 2024 |
| * | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Summary page 5…Product Code ~I_ K2 4_2_9_3_9_ _ _ _ ~ ~A_ R_T_F_X_T_r_a_u _m a_B_o_n_e_P_l_at_e_a_n_d_S_c r_e_w_S_ys_t_e_m_ _ _ _ _ _~ ~I_HR_S_ _ _~ I K143165 Herbert/Whipple Bone Screw System, Herbert Bone Screw, I HWC… | 2015 |
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Summary page 5…Screw, I HWC Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw I K161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | 2017 |
| * | K160946 | 4.0 and 6.5 Cancellous Bone Screw and WasherSummary page 5…Puy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw I K160946 114.0 and 6.5 Cancellous Bone Screw and Washer 1 I HWC Device Descript… | 2016 |
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.
- 61 of the 295 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?
MIKRON TRAUMA BONE PLATE& 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. MIKRON TRAUMA BONE PLATE& SCREW SYSTEM is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine…
Read the full statement (202 words)
MIKRON TRAUMA BONE PLATE& 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. MIKRON TRAUMA BONE PLATE& 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.
MIKRON SMALL FRAGMENT PLATES 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.
MIKRON LARGE FRAGMENT PLATES SYSTEM is indicated for fixation of lower extremity (femur, tibia, fibula) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.
MIKRON STAND-ALONE BONE SCREWS are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Ml KRON MINI PLATES 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/K260277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260277: Mikron Trauma Bone Plate& 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/K260277
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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