510(k) · Cleared
ClearedMontblanc Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medifield Medical Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Jun 4, 2025 as substantially equivalent to K222267 (Arthrex, Inc., 2022) and 1 other predicate after a 217-day review. Its family tree reaches back 11 generations to 2000.
- Decided
- Jun 4, 2025
- Review
- 217 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K000684 (2000). 102 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations between
- 3 generations backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- 2 generations backK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- 1 generation backK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
- This deviceK243368 Montblanc Plate SystemMedifield Medical Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 9 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 8 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 7 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 6 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 5 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 4 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 3 generations backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- 2 generations backK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- 1 generation backK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
- This deviceK243368 Montblanc Plate SystemMedifield Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −10 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −9 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −8 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −7 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −6 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −5 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −4 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −3 | K131474 | Arthrex Distal Radius Plate System | Arthrex, Inc. | 2013 | — |
| −2 | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| −1 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. | 2022 | — |
| 0 (this device) | K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. | 2025 | — |
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 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate SystemSummary page 5…3030 Product Code(s) HRS, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222267 Arthrex 2.4 mm Volar Distal Radius Plate System HRS K123241 Arthrex Fracture Plates HRS K151468 ARIX Wrist System HRS K193616 ARI… | 2022 |
| * | K123241 | Arthrex Fracture PlatesSummary page 5…Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222267 Arthrex 2.4 mm Volar Distal Radius Plate System HRS K123241 Arthrex Fracture Plates HRS K151468 ARIX Wrist System HRS K193616 ARIX Ankle System HRS K170979 ARIX Ankle Fibula Hook Plate Syst… | 2013 |
| † | K151468 | ARIX Wrist System | 2016 |
| † | K193616 | ARIX Ankle System | 2020 |
| † | K170979 | ARIX Ankle Fibula Hook Plate System | 2017 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 102 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Montblanc Radius Plate System
The Montblanc Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.
Montblanc Ankle Plate System
The Montblanc Ankle Plate System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the distal tibia and fibula.
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/K243368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243368: Montblanc Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243368
Report an extraction error
Are you the manufacturer?
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